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Dapaglip
Dapagliflozin Propanediol
Dapaglip
Dapagliflozin Propanediol
Indications
Type 2 DM
Indication detailsView
Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Therapeutic classView
Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors
PharmacologyView
Dapagliflozin is a highly potent, selective, and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that improves glycemic control in patients with type 2 diabetes mellitus by reducing renal glucose reabsorption leading to urinary excretion of excess glucose (glucuresis).
DosageView
5 mg orally once a day. May increase to 10 mg orally once a day in patients tolerating therapy with 5 mg and requiring additional glycemic control
Side effectsView
Renal impairment, Female genital mycotic infections, Urinary tract infection, Increased urination, Male genital mycotic infections, Dyslipidemia, Constipation, Discomfort with urination, Extremity pain, Volume depletion, Hypersensitivity
ContraindicationsView
Hypersensitivity to dapagliflozin propanediol or to any of the excipients. Moderate to severe renal impairment; end-stage renal disease; active bladder cancer. Pregnancy (2nd & 3rd trimester) & lactation.
PrecautionsView
CV disease, history of hypotension, UTI, Children, Elderly. Unknown whether distributed in human breast milk; breastfeeding women should discontinue dapagliflozin or nursing taking into account the importance of the drug to the mother
InteractionsView
Hypoglycemia may occur with concomitant use with insulin & insulin secretagogues eg sulfonylureas. Decrease in Cmax & AUC with rifampin. Increase in Cmax & AUC with mefenamic acid. Increased thiazide & loop diuretic effects; may increase risk of dehydration & hypotension. Pioglitazone.
Pregnancy & lactationView
Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Pediatric usageView
Renal Impairment: No dosage adjustment is indicated based on renal function. The efficacy is dependent on renal function. lt is not recommended for use in patients with moderate to severe renal impairment (patients with CrCI <60 mL/min or eGFR <60 mL/min/1.73 m2).
Daparol
Dapagliflozin Propanediol
Daparol
Dapagliflozin Propanediol
Indications
Type 2 DM
Indication detailsView
Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Therapeutic classView
Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors
PharmacologyView
Dapagliflozin is a highly potent, selective, and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that improves glycemic control in patients with type 2 diabetes mellitus by reducing renal glucose reabsorption leading to urinary excretion of excess glucose (glucuresis).
DosageView
5 mg orally once a day. May increase to 10 mg orally once a day in patients tolerating therapy with 5 mg and requiring additional glycemic control
Side effectsView
Renal impairment, Female genital mycotic infections, Urinary tract infection, Increased urination, Male genital mycotic infections, Dyslipidemia, Constipation, Discomfort with urination, Extremity pain, Volume depletion, Hypersensitivity
ContraindicationsView
Hypersensitivity to dapagliflozin propanediol or to any of the excipients. Moderate to severe renal impairment; end-stage renal disease; active bladder cancer. Pregnancy (2nd & 3rd trimester) & lactation.
PrecautionsView
CV disease, history of hypotension, UTI, Children, Elderly. Unknown whether distributed in human breast milk; breastfeeding women should discontinue dapagliflozin or nursing taking into account the importance of the drug to the mother
InteractionsView
Hypoglycemia may occur with concomitant use with insulin & insulin secretagogues eg sulfonylureas. Decrease in Cmax & AUC with rifampin. Increase in Cmax & AUC with mefenamic acid. Increased thiazide & loop diuretic effects; may increase risk of dehydration & hypotension. Pioglitazone.
Pregnancy & lactationView
Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Pediatric usageView
Renal Impairment: No dosage adjustment is indicated based on renal function. The efficacy is dependent on renal function. lt is not recommended for use in patients with moderate to severe renal impairment (patients with CrCI <60 mL/min or eGFR <60 mL/min/1.73 m2).
Dapawin
Dapagliflozin Propanediol
Dapawin
Dapagliflozin Propanediol
Indications
Type 2 DM
Indication detailsView
Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Therapeutic classView
Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors
PharmacologyView
Dapagliflozin is a highly potent, selective, and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that improves glycemic control in patients with type 2 diabetes mellitus by reducing renal glucose reabsorption leading to urinary excretion of excess glucose (glucuresis).
DosageView
5 mg orally once a day. May increase to 10 mg orally once a day in patients tolerating therapy with 5 mg and requiring additional glycemic control
Side effectsView
Renal impairment, Female genital mycotic infections, Urinary tract infection, Increased urination, Male genital mycotic infections, Dyslipidemia, Constipation, Discomfort with urination, Extremity pain, Volume depletion, Hypersensitivity
ContraindicationsView
Hypersensitivity to dapagliflozin propanediol or to any of the excipients. Moderate to severe renal impairment; end-stage renal disease; active bladder cancer. Pregnancy (2nd & 3rd trimester) & lactation.
PrecautionsView
CV disease, history of hypotension, UTI, Children, Elderly. Unknown whether distributed in human breast milk; breastfeeding women should discontinue dapagliflozin or nursing taking into account the importance of the drug to the mother
InteractionsView
Hypoglycemia may occur with concomitant use with insulin & insulin secretagogues eg sulfonylureas. Decrease in Cmax & AUC with rifampin. Increase in Cmax & AUC with mefenamic acid. Increased thiazide & loop diuretic effects; may increase risk of dehydration & hypotension. Pioglitazone.
Pregnancy & lactationView
Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Pediatric usageView
Renal Impairment: No dosage adjustment is indicated based on renal function. The efficacy is dependent on renal function. lt is not recommended for use in patients with moderate to severe renal impairment (patients with CrCI <60 mL/min or eGFR <60 mL/min/1.73 m2).
Dapazin
Dapagliflozin Propanediol
Dapazin
Dapagliflozin Propanediol
Indications
Type 2 DM
Indication detailsView
Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Therapeutic classView
Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors
PharmacologyView
Dapagliflozin is a highly potent, selective, and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that improves glycemic control in patients with type 2 diabetes mellitus by reducing renal glucose reabsorption leading to urinary excretion of excess glucose (glucuresis).
DosageView
5 mg orally once a day. May increase to 10 mg orally once a day in patients tolerating therapy with 5 mg and requiring additional glycemic control
Side effectsView
Renal impairment, Female genital mycotic infections, Urinary tract infection, Increased urination, Male genital mycotic infections, Dyslipidemia, Constipation, Discomfort with urination, Extremity pain, Volume depletion, Hypersensitivity
ContraindicationsView
Hypersensitivity to dapagliflozin propanediol or to any of the excipients. Moderate to severe renal impairment; end-stage renal disease; active bladder cancer. Pregnancy (2nd & 3rd trimester) & lactation.
PrecautionsView
CV disease, history of hypotension, UTI, Children, Elderly. Unknown whether distributed in human breast milk; breastfeeding women should discontinue dapagliflozin or nursing taking into account the importance of the drug to the mother
InteractionsView
Hypoglycemia may occur with concomitant use with insulin & insulin secretagogues eg sulfonylureas. Decrease in Cmax & AUC with rifampin. Increase in Cmax & AUC with mefenamic acid. Increased thiazide & loop diuretic effects; may increase risk of dehydration & hypotension. Pioglitazone.
Pregnancy & lactationView
Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Pediatric usageView
Renal Impairment: No dosage adjustment is indicated based on renal function. The efficacy is dependent on renal function. lt is not recommended for use in patients with moderate to severe renal impairment (patients with CrCI <60 mL/min or eGFR <60 mL/min/1.73 m2).
Dapazin
Dapagliflozin Propanediol
Dapazin
Dapagliflozin Propanediol
Indications
Type 2 DM
Indication detailsView
Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Therapeutic classView
Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors
PharmacologyView
Dapagliflozin is a highly potent, selective, and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that improves glycemic control in patients with type 2 diabetes mellitus by reducing renal glucose reabsorption leading to urinary excretion of excess glucose (glucuresis).
DosageView
5 mg orally once a day. May increase to 10 mg orally once a day in patients tolerating therapy with 5 mg and requiring additional glycemic control
Side effectsView
Renal impairment, Female genital mycotic infections, Urinary tract infection, Increased urination, Male genital mycotic infections, Dyslipidemia, Constipation, Discomfort with urination, Extremity pain, Volume depletion, Hypersensitivity
ContraindicationsView
Hypersensitivity to dapagliflozin propanediol or to any of the excipients. Moderate to severe renal impairment; end-stage renal disease; active bladder cancer. Pregnancy (2nd & 3rd trimester) & lactation.
PrecautionsView
CV disease, history of hypotension, UTI, Children, Elderly. Unknown whether distributed in human breast milk; breastfeeding women should discontinue dapagliflozin or nursing taking into account the importance of the drug to the mother
InteractionsView
Hypoglycemia may occur with concomitant use with insulin & insulin secretagogues eg sulfonylureas. Decrease in Cmax & AUC with rifampin. Increase in Cmax & AUC with mefenamic acid. Increased thiazide & loop diuretic effects; may increase risk of dehydration & hypotension. Pioglitazone.
Pregnancy & lactationView
Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Pediatric usageView
Renal Impairment: No dosage adjustment is indicated based on renal function. The efficacy is dependent on renal function. lt is not recommended for use in patients with moderate to severe renal impairment (patients with CrCI <60 mL/min or eGFR <60 mL/min/1.73 m2).
Dapclin
Dapsone
Dapclin
Dapsone
Indications
Acne vulgaris
Indication detailsView
Dapsone is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Therapeutic classView
Acne treatment preparations
PharmacologyView
Dapsone has both anti-infammatory and antimicrobial properties. A combination of these activities may account for its efcacy in acne. Anti-infammatory efects include inhibition of neutrophil myeloperoxidase and eosinophil peroxidase activity, suppression of hypochlorous acid production, scavenging of reactive oxygen species, suppression of neutrophil activity, and inhibition of chemoattractant-induced signal transduction. Antimicrobial activity, similar to that of sulfones and sulfonamides, is by inhibition of bacterial dihydropteroate synthase in the folic acid metabolic pathway. This mechanism is efective against microorganisms synthesizing their own folic acid. In vitro susceptibility testing has demonstrated some activity for Dapsone against Propionibacterium species, including Propionibacterium acnes (P. acnes).
DosageView
After the skin is gently washed and patted dry, apply approximately a pea-sized amount of Dapsone in a thin layer to the entire face once daily. In addition, a thin layer may be applied to other afected areas once daily. Rub in Dapsone, gently and completely. If there is no improvement after 12 weeks, treatment with Dapsone should be reassessed. Not for oral, ophthalmic or intravaginal use.
Side effectsView
Most common (incidence ≥ 0.9%) effects are application site dryness and pruritus.
ContraindicationsView
Those who are hypersensitive to Dapsone.
PrecautionsView
Methemoglobinemia: Cases of methemoglobinemia have been reported. Discontinue Dapsone if signs of methemoglobinemia occur.
Hemolysis: Some patients with Glucose-6-Phosphate Dehydrogenase (G6PD) defciency using topical Dapsone developed laboratory changes suggestive of hemolysis.
Hemolysis: Some patients with Glucose-6-Phosphate Dehydrogenase (G6PD) defciency using topical Dapsone developed laboratory changes suggestive of hemolysis.
InteractionsView
Trimethoprim/ sulfamethoxazole (TMP/ SMX) increases the systemic level of Dapsone and its metabolites.
Topical benzoyl peroxide used at the same time as Dapsone may result in temporary local yellow or orange skin discoloration.
Topical benzoyl peroxide used at the same time as Dapsone may result in temporary local yellow or orange skin discoloration.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. Dapsone should be used during pregnancy only if the potential beneft justifes the potential risk to the fetus.
Although systemic absorption of Dapsone following topical application of Dapsone is minimal relative to oral Dapsone administration, it is known that Dapsone is excreted in human milk. Because of the potential for oral Dapsone to cause adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Dapsone, taking into account the importance of the drug to the mother.
Although systemic absorption of Dapsone following topical application of Dapsone is minimal relative to oral Dapsone administration, it is known that Dapsone is excreted in human milk. Because of the potential for oral Dapsone to cause adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Dapsone, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric Use: Safety and efectiveness of Dapsone have not been established in pediatric patients below the age of 12 years.
Geriatric Use: Clinical trials of Dapsone did not include sufcient numbers of subjects aged 65 years and over to determine whether they respond diferently from younger subjects.
Geriatric Use: Clinical trials of Dapsone did not include sufcient numbers of subjects aged 65 years and over to determine whether they respond diferently from younger subjects.
StorageView
Store in a cool & dry place. Keep out of reach of children. Do not freeze.
Dapclin
Dapsone
Dapclin
Dapsone
Indications
Acne vulgaris
Indication detailsView
Dapsone is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Therapeutic classView
Acne treatment preparations
PharmacologyView
Dapsone has both anti-infammatory and antimicrobial properties. A combination of these activities may account for its efcacy in acne. Anti-infammatory efects include inhibition of neutrophil myeloperoxidase and eosinophil peroxidase activity, suppression of hypochlorous acid production, scavenging of reactive oxygen species, suppression of neutrophil activity, and inhibition of chemoattractant-induced signal transduction. Antimicrobial activity, similar to that of sulfones and sulfonamides, is by inhibition of bacterial dihydropteroate synthase in the folic acid metabolic pathway. This mechanism is efective against microorganisms synthesizing their own folic acid. In vitro susceptibility testing has demonstrated some activity for Dapsone against Propionibacterium species, including Propionibacterium acnes (P. acnes).
DosageView
After the skin is gently washed and patted dry, apply approximately a pea-sized amount of Dapsone in a thin layer to the entire face once daily. In addition, a thin layer may be applied to other afected areas once daily. Rub in Dapsone, gently and completely. If there is no improvement after 12 weeks, treatment with Dapsone should be reassessed. Not for oral, ophthalmic or intravaginal use.
Side effectsView
Most common (incidence ≥ 0.9%) effects are application site dryness and pruritus.
ContraindicationsView
Those who are hypersensitive to Dapsone.
PrecautionsView
Methemoglobinemia: Cases of methemoglobinemia have been reported. Discontinue Dapsone if signs of methemoglobinemia occur.
Hemolysis: Some patients with Glucose-6-Phosphate Dehydrogenase (G6PD) defciency using topical Dapsone developed laboratory changes suggestive of hemolysis.
Hemolysis: Some patients with Glucose-6-Phosphate Dehydrogenase (G6PD) defciency using topical Dapsone developed laboratory changes suggestive of hemolysis.
InteractionsView
Trimethoprim/ sulfamethoxazole (TMP/ SMX) increases the systemic level of Dapsone and its metabolites.
Topical benzoyl peroxide used at the same time as Dapsone may result in temporary local yellow or orange skin discoloration.
Topical benzoyl peroxide used at the same time as Dapsone may result in temporary local yellow or orange skin discoloration.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. Dapsone should be used during pregnancy only if the potential beneft justifes the potential risk to the fetus.
Although systemic absorption of Dapsone following topical application of Dapsone is minimal relative to oral Dapsone administration, it is known that Dapsone is excreted in human milk. Because of the potential for oral Dapsone to cause adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Dapsone, taking into account the importance of the drug to the mother.
Although systemic absorption of Dapsone following topical application of Dapsone is minimal relative to oral Dapsone administration, it is known that Dapsone is excreted in human milk. Because of the potential for oral Dapsone to cause adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Dapsone, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric Use: Safety and efectiveness of Dapsone have not been established in pediatric patients below the age of 12 years.
Geriatric Use: Clinical trials of Dapsone did not include sufcient numbers of subjects aged 65 years and over to determine whether they respond diferently from younger subjects.
Geriatric Use: Clinical trials of Dapsone did not include sufcient numbers of subjects aged 65 years and over to determine whether they respond diferently from younger subjects.
StorageView
Store in a cool & dry place. Keep out of reach of children. Do not freeze.
Dapgel
Dapsone
Dapgel
Dapsone
Indications
Acne vulgaris
Indication detailsView
Dapsone is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Therapeutic classView
Acne treatment preparations
PharmacologyView
Dapsone has both anti-infammatory and antimicrobial properties. A combination of these activities may account for its efcacy in acne. Anti-infammatory efects include inhibition of neutrophil myeloperoxidase and eosinophil peroxidase activity, suppression of hypochlorous acid production, scavenging of reactive oxygen species, suppression of neutrophil activity, and inhibition of chemoattractant-induced signal transduction. Antimicrobial activity, similar to that of sulfones and sulfonamides, is by inhibition of bacterial dihydropteroate synthase in the folic acid metabolic pathway. This mechanism is efective against microorganisms synthesizing their own folic acid. In vitro susceptibility testing has demonstrated some activity for Dapsone against Propionibacterium species, including Propionibacterium acnes (P. acnes).
DosageView
After the skin is gently washed and patted dry, apply approximately a pea-sized amount of Dapsone in a thin layer to the entire face once daily. In addition, a thin layer may be applied to other afected areas once daily. Rub in Dapsone, gently and completely. If there is no improvement after 12 weeks, treatment with Dapsone should be reassessed. Not for oral, ophthalmic or intravaginal use.
Side effectsView
Most common (incidence ≥ 0.9%) effects are application site dryness and pruritus.
ContraindicationsView
Those who are hypersensitive to Dapsone.
PrecautionsView
Methemoglobinemia: Cases of methemoglobinemia have been reported. Discontinue Dapsone if signs of methemoglobinemia occur.
Hemolysis: Some patients with Glucose-6-Phosphate Dehydrogenase (G6PD) defciency using topical Dapsone developed laboratory changes suggestive of hemolysis.
Hemolysis: Some patients with Glucose-6-Phosphate Dehydrogenase (G6PD) defciency using topical Dapsone developed laboratory changes suggestive of hemolysis.
InteractionsView
Trimethoprim/ sulfamethoxazole (TMP/ SMX) increases the systemic level of Dapsone and its metabolites.
Topical benzoyl peroxide used at the same time as Dapsone may result in temporary local yellow or orange skin discoloration.
Topical benzoyl peroxide used at the same time as Dapsone may result in temporary local yellow or orange skin discoloration.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. Dapsone should be used during pregnancy only if the potential beneft justifes the potential risk to the fetus.
Although systemic absorption of Dapsone following topical application of Dapsone is minimal relative to oral Dapsone administration, it is known that Dapsone is excreted in human milk. Because of the potential for oral Dapsone to cause adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Dapsone, taking into account the importance of the drug to the mother.
Although systemic absorption of Dapsone following topical application of Dapsone is minimal relative to oral Dapsone administration, it is known that Dapsone is excreted in human milk. Because of the potential for oral Dapsone to cause adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Dapsone, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric Use: Safety and efectiveness of Dapsone have not been established in pediatric patients below the age of 12 years.
Geriatric Use: Clinical trials of Dapsone did not include sufcient numbers of subjects aged 65 years and over to determine whether they respond diferently from younger subjects.
Geriatric Use: Clinical trials of Dapsone did not include sufcient numbers of subjects aged 65 years and over to determine whether they respond diferently from younger subjects.
StorageView
Store in a cool & dry place. Keep out of reach of children. Do not freeze.
Daporex
Dapoxetine Hydrochloride
Daporex
Dapoxetine Hydrochloride
Indications
Premature ejaculation
Indication detailsView
Indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have all of the following:
- Persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the patient wishes.
- Marked personal distress or interpersonal difficulty as a consequence of PE and poor control over ejaculation.
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
The mechanism of action is thought to be related to inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin activity. The central ejaculatory neural circuit comprises spinal and cerebral areas that form a highly interconnected network. The sympathetic, parasympathetic, and somatic spinal centers, under the influence of sensory genital and cerebral stimuli integrated and processed at the spinal cord level, act in synergy to command physiologic events occurring during ejaculation. Experimental evidence indicates that serotonin (5-HT), throughout brain descending pathways, exerts an inhibitory role on ejaculation. To date, three 5-HT receptor subtypes 5-HT(1A), 5-HT(1B), and 5-HT(2C) have been postulated to mediate 5-HT's modulating activity on ejaculation.
DosageView
Adult (18 to 64 years of age): The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. The maximum recommended dosing frequency is one dose every 24 hours.
Side effectsView
Dizziness, Headache, Somnolence, Tremor, Blurred vision, Tinnitus, Sinus congestion, Nausea, Diarrhea, Abdominal pain, Dry mouth, Fatigue, Insomnia, Hypertension.
ContraindicationsView
- Patients with known hypersensitivity to Dapoxetine Hydrochloride.
- Patients with significant pathological cardiac conditions such as heart failure (NYHA class II-IV), conduction abnormalities (second or third degree AV block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease of significant valvular disease.
- Concomitant treatment with monoamine oxidase inhibitors (MAOIs), thioridazine. Similarly, MAOIs or thioridazine should not be administered within 7 days after Dapoxetine has been discontinued.
- Concomitant treatment with serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs) or other medicinal/herbal products with serotonergic effects or within 14 days of discontinuing treatment with these medicinal/herbal products.
PrecautionsView
Patient with bleeding disorders, epilepsy, susceptibility to angle-closure glaucoma or raised intraocular pressure. Not intended for use in women. Known CYP2D6 poor metabolisers.
InteractionsView
CNS active medicinal products: The use of Dapoxetine in combination with CNS active medicinal products has not been systematically evaluated in patients with premature ejaculation. Consequently, caution is advised if the concomitant administration of Dapoxetine and such medicinal products is required.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
Pregnancy & lactationView
Dapoxetine is not indicated for use by women. It is not known either dapoxetine or its metabolites are excreted through human breast milk.
Overdose effectsView
There were no unexpected adverse events in a clinical pharmacology study of Dapoxetine with daily doses up to 240 mg. In general, symptoms of overdose with SSRIs include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness. In cases of overdose, standard supportive measures should be adopted as required.
StorageView
Store below 30°C. Protect from light and moisture. Keep out of reach of children
Daporex
Dapoxetine Hydrochloride
Daporex
Dapoxetine Hydrochloride
Indications
Premature ejaculation
Indication detailsView
Indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have all of the following:
- Persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the patient wishes.
- Marked personal distress or interpersonal difficulty as a consequence of PE and poor control over ejaculation.
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
The mechanism of action is thought to be related to inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin activity. The central ejaculatory neural circuit comprises spinal and cerebral areas that form a highly interconnected network. The sympathetic, parasympathetic, and somatic spinal centers, under the influence of sensory genital and cerebral stimuli integrated and processed at the spinal cord level, act in synergy to command physiologic events occurring during ejaculation. Experimental evidence indicates that serotonin (5-HT), throughout brain descending pathways, exerts an inhibitory role on ejaculation. To date, three 5-HT receptor subtypes 5-HT(1A), 5-HT(1B), and 5-HT(2C) have been postulated to mediate 5-HT's modulating activity on ejaculation.
DosageView
Adult (18 to 64 years of age): The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. The maximum recommended dosing frequency is one dose every 24 hours.
Side effectsView
Dizziness, Headache, Somnolence, Tremor, Blurred vision, Tinnitus, Sinus congestion, Nausea, Diarrhea, Abdominal pain, Dry mouth, Fatigue, Insomnia, Hypertension.
ContraindicationsView
- Patients with known hypersensitivity to Dapoxetine Hydrochloride.
- Patients with significant pathological cardiac conditions such as heart failure (NYHA class II-IV), conduction abnormalities (second or third degree AV block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease of significant valvular disease.
- Concomitant treatment with monoamine oxidase inhibitors (MAOIs), thioridazine. Similarly, MAOIs or thioridazine should not be administered within 7 days after Dapoxetine has been discontinued.
- Concomitant treatment with serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs) or other medicinal/herbal products with serotonergic effects or within 14 days of discontinuing treatment with these medicinal/herbal products.
PrecautionsView
Patient with bleeding disorders, epilepsy, susceptibility to angle-closure glaucoma or raised intraocular pressure. Not intended for use in women. Known CYP2D6 poor metabolisers.
InteractionsView
CNS active medicinal products: The use of Dapoxetine in combination with CNS active medicinal products has not been systematically evaluated in patients with premature ejaculation. Consequently, caution is advised if the concomitant administration of Dapoxetine and such medicinal products is required.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
Pregnancy & lactationView
Dapoxetine is not indicated for use by women. It is not known either dapoxetine or its metabolites are excreted through human breast milk.
Overdose effectsView
There were no unexpected adverse events in a clinical pharmacology study of Dapoxetine with daily doses up to 240 mg. In general, symptoms of overdose with SSRIs include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness. In cases of overdose, standard supportive measures should be adopted as required.
StorageView
Store below 30°C. Protect from light and moisture. Keep out of reach of children
Dapotin
Dapoxetine Hydrochloride
Dapotin
Dapoxetine Hydrochloride
Indications
Premature ejaculation
Indication detailsView
Indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have all of the following:
- Persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the patient wishes.
- Marked personal distress or interpersonal difficulty as a consequence of PE and poor control over ejaculation.
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
The mechanism of action is thought to be related to inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin activity. The central ejaculatory neural circuit comprises spinal and cerebral areas that form a highly interconnected network. The sympathetic, parasympathetic, and somatic spinal centers, under the influence of sensory genital and cerebral stimuli integrated and processed at the spinal cord level, act in synergy to command physiologic events occurring during ejaculation. Experimental evidence indicates that serotonin (5-HT), throughout brain descending pathways, exerts an inhibitory role on ejaculation. To date, three 5-HT receptor subtypes 5-HT(1A), 5-HT(1B), and 5-HT(2C) have been postulated to mediate 5-HT's modulating activity on ejaculation.
DosageView
Adult (18 to 64 years of age): The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. The maximum recommended dosing frequency is one dose every 24 hours.
Side effectsView
Dizziness, Headache, Somnolence, Tremor, Blurred vision, Tinnitus, Sinus congestion, Nausea, Diarrhea, Abdominal pain, Dry mouth, Fatigue, Insomnia, Hypertension.
ContraindicationsView
- Patients with known hypersensitivity to Dapoxetine Hydrochloride.
- Patients with significant pathological cardiac conditions such as heart failure (NYHA class II-IV), conduction abnormalities (second or third degree AV block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease of significant valvular disease.
- Concomitant treatment with monoamine oxidase inhibitors (MAOIs), thioridazine. Similarly, MAOIs or thioridazine should not be administered within 7 days after Dapoxetine has been discontinued.
- Concomitant treatment with serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs) or other medicinal/herbal products with serotonergic effects or within 14 days of discontinuing treatment with these medicinal/herbal products.
PrecautionsView
Patient with bleeding disorders, epilepsy, susceptibility to angle-closure glaucoma or raised intraocular pressure. Not intended for use in women. Known CYP2D6 poor metabolisers.
InteractionsView
CNS active medicinal products: The use of Dapoxetine in combination with CNS active medicinal products has not been systematically evaluated in patients with premature ejaculation. Consequently, caution is advised if the concomitant administration of Dapoxetine and such medicinal products is required.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
Pregnancy & lactationView
Dapoxetine is not indicated for use by women. It is not known either dapoxetine or its metabolites are excreted through human breast milk.
Overdose effectsView
There were no unexpected adverse events in a clinical pharmacology study of Dapoxetine with daily doses up to 240 mg. In general, symptoms of overdose with SSRIs include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness. In cases of overdose, standard supportive measures should be adopted as required.
StorageView
Store below 30°C. Protect from light and moisture. Keep out of reach of children
Dapoxen
Dapoxetine Hydrochloride
Dapoxen
Dapoxetine Hydrochloride
Indications
Premature ejaculation
Indication detailsView
Indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have all of the following:
- Persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the patient wishes.
- Marked personal distress or interpersonal difficulty as a consequence of PE and poor control over ejaculation.
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
The mechanism of action is thought to be related to inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin activity. The central ejaculatory neural circuit comprises spinal and cerebral areas that form a highly interconnected network. The sympathetic, parasympathetic, and somatic spinal centers, under the influence of sensory genital and cerebral stimuli integrated and processed at the spinal cord level, act in synergy to command physiologic events occurring during ejaculation. Experimental evidence indicates that serotonin (5-HT), throughout brain descending pathways, exerts an inhibitory role on ejaculation. To date, three 5-HT receptor subtypes 5-HT(1A), 5-HT(1B), and 5-HT(2C) have been postulated to mediate 5-HT's modulating activity on ejaculation.
DosageView
Adult (18 to 64 years of age): The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. The maximum recommended dosing frequency is one dose every 24 hours.
Side effectsView
Dizziness, Headache, Somnolence, Tremor, Blurred vision, Tinnitus, Sinus congestion, Nausea, Diarrhea, Abdominal pain, Dry mouth, Fatigue, Insomnia, Hypertension.
ContraindicationsView
- Patients with known hypersensitivity to Dapoxetine Hydrochloride.
- Patients with significant pathological cardiac conditions such as heart failure (NYHA class II-IV), conduction abnormalities (second or third degree AV block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease of significant valvular disease.
- Concomitant treatment with monoamine oxidase inhibitors (MAOIs), thioridazine. Similarly, MAOIs or thioridazine should not be administered within 7 days after Dapoxetine has been discontinued.
- Concomitant treatment with serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs) or other medicinal/herbal products with serotonergic effects or within 14 days of discontinuing treatment with these medicinal/herbal products.
PrecautionsView
Patient with bleeding disorders, epilepsy, susceptibility to angle-closure glaucoma or raised intraocular pressure. Not intended for use in women. Known CYP2D6 poor metabolisers.
InteractionsView
CNS active medicinal products: The use of Dapoxetine in combination with CNS active medicinal products has not been systematically evaluated in patients with premature ejaculation. Consequently, caution is advised if the concomitant administration of Dapoxetine and such medicinal products is required.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
Pregnancy & lactationView
Dapoxetine is not indicated for use by women. It is not known either dapoxetine or its metabolites are excreted through human breast milk.
Overdose effectsView
There were no unexpected adverse events in a clinical pharmacology study of Dapoxetine with daily doses up to 240 mg. In general, symptoms of overdose with SSRIs include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness. In cases of overdose, standard supportive measures should be adopted as required.
StorageView
Store below 30°C. Protect from light and moisture. Keep out of reach of children
Dapoxen
Dapoxetine Hydrochloride
Dapoxen
Dapoxetine Hydrochloride
Indications
Premature ejaculation
Indication detailsView
Indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have all of the following:
- Persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the patient wishes.
- Marked personal distress or interpersonal difficulty as a consequence of PE and poor control over ejaculation.
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
The mechanism of action is thought to be related to inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin activity. The central ejaculatory neural circuit comprises spinal and cerebral areas that form a highly interconnected network. The sympathetic, parasympathetic, and somatic spinal centers, under the influence of sensory genital and cerebral stimuli integrated and processed at the spinal cord level, act in synergy to command physiologic events occurring during ejaculation. Experimental evidence indicates that serotonin (5-HT), throughout brain descending pathways, exerts an inhibitory role on ejaculation. To date, three 5-HT receptor subtypes 5-HT(1A), 5-HT(1B), and 5-HT(2C) have been postulated to mediate 5-HT's modulating activity on ejaculation.
DosageView
Adult (18 to 64 years of age): The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. The maximum recommended dosing frequency is one dose every 24 hours.
Side effectsView
Dizziness, Headache, Somnolence, Tremor, Blurred vision, Tinnitus, Sinus congestion, Nausea, Diarrhea, Abdominal pain, Dry mouth, Fatigue, Insomnia, Hypertension.
ContraindicationsView
- Patients with known hypersensitivity to Dapoxetine Hydrochloride.
- Patients with significant pathological cardiac conditions such as heart failure (NYHA class II-IV), conduction abnormalities (second or third degree AV block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease of significant valvular disease.
- Concomitant treatment with monoamine oxidase inhibitors (MAOIs), thioridazine. Similarly, MAOIs or thioridazine should not be administered within 7 days after Dapoxetine has been discontinued.
- Concomitant treatment with serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs) or other medicinal/herbal products with serotonergic effects or within 14 days of discontinuing treatment with these medicinal/herbal products.
PrecautionsView
Patient with bleeding disorders, epilepsy, susceptibility to angle-closure glaucoma or raised intraocular pressure. Not intended for use in women. Known CYP2D6 poor metabolisers.
InteractionsView
CNS active medicinal products: The use of Dapoxetine in combination with CNS active medicinal products has not been systematically evaluated in patients with premature ejaculation. Consequently, caution is advised if the concomitant administration of Dapoxetine and such medicinal products is required.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.
Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.
Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.
Pregnancy & lactationView
Dapoxetine is not indicated for use by women. It is not known either dapoxetine or its metabolites are excreted through human breast milk.
Overdose effectsView
There were no unexpected adverse events in a clinical pharmacology study of Dapoxetine with daily doses up to 240 mg. In general, symptoms of overdose with SSRIs include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness. In cases of overdose, standard supportive measures should be adopted as required.
StorageView
Store below 30°C. Protect from light and moisture. Keep out of reach of children
Darbesis
Darbepoetin Alfa
Darbesis
Darbepoetin Alfa
Indications
Anaemia
Indication detailsView
Anemia Due To Chronic Kidney Disease: Darbepoetin Alfa is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Therapeutic classView
Haematopoietic Agents
PharmacologyView
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Erythropoietin interacts with progenitor stem cells to increase red cell production. Binding of erythropoietin to the erythropoietin receptor leads to receptor dimerization, which facilitates activation of JAK-STAT signaling pathways within the cytosol. Activated STAT (signal transducers and activators of transcription) proteins are then translocated to the nucleus where they serve as transcription factors which regulate the activation of specific genes involved in cell division or differentiation.
DosageView
Usual Adult Dose for Anemia Associated with Chronic Renal Failure:
Chronic Kidney Disease (CKD) Patients Not on Dialysis:- Initial dose: 0.45 mcg/kg IV or subcutaneously once every 4 weeks as appropriate
- Comments: Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
- Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate
- Comments: Initiate treatment when hemoglobin is less than 10 g/dL. IV route is recommended for patients on hemodialysis.
Usual Adult Dose for Anemia Associated with Chemotherapy:
- Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeks
- Duration of therapy: Until completion of chemotherapy course
- Comments: Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned. Use the lowest dose necessary to avoid RBC transfusions.
- Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.
Side effectsView
Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism; Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with cancer; Hypertension; Seizures; Serious allergic reaction; Severe Cutaneous Reactions
ContraindicationsView
Darbepoetin is contraindicated in patients with:
- Uncontrolled hypertension
- Pure red cell aplasia (PRCA) that begins after treatment with Darbepoetin or other erythropoietin protein drugs
- Serious allergic reactions to Darbepoetin
PrecautionsView
Pregnancy and lactation, children. Hypertension; history of seizures; hepatic impairment; sickle cell anaemia; sudden stabing migraine-like pain (warning sign of hypotensive crisis); exclude other causes of anaemia; ischaemic vascular disease; thrombocytosis; epilepsy; malignant disease; increase in heparin dose may be needed; increased risk of thrombosis when used for anaemia before orthopedic surgery; CV disease including recent MI/cerebrovascular accident. Monitor haemoglobin, BP and electrolytes; platelet count for 1st 8 wk.
InteractionsView
Antagonism of hypotensive effect and increased risk of hyperkalemia with ACE inhibitors and angiotensin II receptor antagonists. Ethanol.
Pregnancy & lactationView
Pregnancy Category C. It is not known whether Darbepoetin Alfa is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Darbepoetin Alfa is administered to a nursing woman.
Pediatric usageView
Pediatric Use:
- Pediatric Patients With CKD: Darbepoetin safety and efficacy were similar between adults and pediatric patients with CKD when Darbepoetin was used for initial treatment of anemia or patients were transitioned from treatment with epoetin alfa to Darbepoetin
- Pediatric Patients With Cancer: The safety and efficacy of Darbepoetin in pediatric patients with cancer have not been established.
Overdose effectsView
Darbepoetin overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Darbepoetin dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs
StorageView
Store at 2°C to 8°C. Do not freeze. Do not shake. Protect from light; store Darbepoetin Alfa in the carton until use. Do not use Darbepoetin Alfa that has been shaken or frozen.
Darbesis
Darbepoetin Alfa
Darbesis
Darbepoetin Alfa
Indications
Anaemia
Indication detailsView
Anemia Due To Chronic Kidney Disease: Darbepoetin Alfa is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Therapeutic classView
Haematopoietic Agents
PharmacologyView
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Erythropoietin interacts with progenitor stem cells to increase red cell production. Binding of erythropoietin to the erythropoietin receptor leads to receptor dimerization, which facilitates activation of JAK-STAT signaling pathways within the cytosol. Activated STAT (signal transducers and activators of transcription) proteins are then translocated to the nucleus where they serve as transcription factors which regulate the activation of specific genes involved in cell division or differentiation.
DosageView
Usual Adult Dose for Anemia Associated with Chronic Renal Failure:
Chronic Kidney Disease (CKD) Patients Not on Dialysis:- Initial dose: 0.45 mcg/kg IV or subcutaneously once every 4 weeks as appropriate
- Comments: Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
- Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate
- Comments: Initiate treatment when hemoglobin is less than 10 g/dL. IV route is recommended for patients on hemodialysis.
Usual Adult Dose for Anemia Associated with Chemotherapy:
- Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeks
- Duration of therapy: Until completion of chemotherapy course
- Comments: Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned. Use the lowest dose necessary to avoid RBC transfusions.
- Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.
Side effectsView
Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism; Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with cancer; Hypertension; Seizures; Serious allergic reaction; Severe Cutaneous Reactions
ContraindicationsView
Darbepoetin is contraindicated in patients with:
- Uncontrolled hypertension
- Pure red cell aplasia (PRCA) that begins after treatment with Darbepoetin or other erythropoietin protein drugs
- Serious allergic reactions to Darbepoetin
PrecautionsView
Pregnancy and lactation, children. Hypertension; history of seizures; hepatic impairment; sickle cell anaemia; sudden stabing migraine-like pain (warning sign of hypotensive crisis); exclude other causes of anaemia; ischaemic vascular disease; thrombocytosis; epilepsy; malignant disease; increase in heparin dose may be needed; increased risk of thrombosis when used for anaemia before orthopedic surgery; CV disease including recent MI/cerebrovascular accident. Monitor haemoglobin, BP and electrolytes; platelet count for 1st 8 wk.
InteractionsView
Antagonism of hypotensive effect and increased risk of hyperkalemia with ACE inhibitors and angiotensin II receptor antagonists. Ethanol.
Pregnancy & lactationView
Pregnancy Category C. It is not known whether Darbepoetin Alfa is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Darbepoetin Alfa is administered to a nursing woman.
Pediatric usageView
Pediatric Use:
- Pediatric Patients With CKD: Darbepoetin safety and efficacy were similar between adults and pediatric patients with CKD when Darbepoetin was used for initial treatment of anemia or patients were transitioned from treatment with epoetin alfa to Darbepoetin
- Pediatric Patients With Cancer: The safety and efficacy of Darbepoetin in pediatric patients with cancer have not been established.
Overdose effectsView
Darbepoetin overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Darbepoetin dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs
StorageView
Store at 2°C to 8°C. Do not freeze. Do not shake. Protect from light; store Darbepoetin Alfa in the carton until use. Do not use Darbepoetin Alfa that has been shaken or frozen.
Darbesis
Darbepoetin Alfa
Darbesis
Darbepoetin Alfa
Indications
Anaemia
Indication detailsView
Anemia Due To Chronic Kidney Disease: Darbepoetin Alfa is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Therapeutic classView
Haematopoietic Agents
PharmacologyView
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Erythropoietin interacts with progenitor stem cells to increase red cell production. Binding of erythropoietin to the erythropoietin receptor leads to receptor dimerization, which facilitates activation of JAK-STAT signaling pathways within the cytosol. Activated STAT (signal transducers and activators of transcription) proteins are then translocated to the nucleus where they serve as transcription factors which regulate the activation of specific genes involved in cell division or differentiation.
DosageView
Usual Adult Dose for Anemia Associated with Chronic Renal Failure:
Chronic Kidney Disease (CKD) Patients Not on Dialysis:- Initial dose: 0.45 mcg/kg IV or subcutaneously once every 4 weeks as appropriate
- Comments: Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
- Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate
- Comments: Initiate treatment when hemoglobin is less than 10 g/dL. IV route is recommended for patients on hemodialysis.
Usual Adult Dose for Anemia Associated with Chemotherapy:
- Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeks
- Duration of therapy: Until completion of chemotherapy course
- Comments: Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned. Use the lowest dose necessary to avoid RBC transfusions.
- Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.
Side effectsView
Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism; Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with cancer; Hypertension; Seizures; Serious allergic reaction; Severe Cutaneous Reactions
ContraindicationsView
Darbepoetin is contraindicated in patients with:
- Uncontrolled hypertension
- Pure red cell aplasia (PRCA) that begins after treatment with Darbepoetin or other erythropoietin protein drugs
- Serious allergic reactions to Darbepoetin
PrecautionsView
Pregnancy and lactation, children. Hypertension; history of seizures; hepatic impairment; sickle cell anaemia; sudden stabing migraine-like pain (warning sign of hypotensive crisis); exclude other causes of anaemia; ischaemic vascular disease; thrombocytosis; epilepsy; malignant disease; increase in heparin dose may be needed; increased risk of thrombosis when used for anaemia before orthopedic surgery; CV disease including recent MI/cerebrovascular accident. Monitor haemoglobin, BP and electrolytes; platelet count for 1st 8 wk.
InteractionsView
Antagonism of hypotensive effect and increased risk of hyperkalemia with ACE inhibitors and angiotensin II receptor antagonists. Ethanol.
Pregnancy & lactationView
Pregnancy Category C. It is not known whether Darbepoetin Alfa is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Darbepoetin Alfa is administered to a nursing woman.
Pediatric usageView
Pediatric Use:
- Pediatric Patients With CKD: Darbepoetin safety and efficacy were similar between adults and pediatric patients with CKD when Darbepoetin was used for initial treatment of anemia or patients were transitioned from treatment with epoetin alfa to Darbepoetin
- Pediatric Patients With Cancer: The safety and efficacy of Darbepoetin in pediatric patients with cancer have not been established.
Overdose effectsView
Darbepoetin overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Darbepoetin dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs
StorageView
Store at 2°C to 8°C. Do not freeze. Do not shake. Protect from light; store Darbepoetin Alfa in the carton until use. Do not use Darbepoetin Alfa that has been shaken or frozen.
Darbetin
Darbepoetin Alfa
Darbetin
Darbepoetin Alfa
Indications
Anaemia
Indication detailsView
Anemia Due To Chronic Kidney Disease: Darbepoetin Alfa is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Therapeutic classView
Haematopoietic Agents
PharmacologyView
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Erythropoietin interacts with progenitor stem cells to increase red cell production. Binding of erythropoietin to the erythropoietin receptor leads to receptor dimerization, which facilitates activation of JAK-STAT signaling pathways within the cytosol. Activated STAT (signal transducers and activators of transcription) proteins are then translocated to the nucleus where they serve as transcription factors which regulate the activation of specific genes involved in cell division or differentiation.
DosageView
Usual Adult Dose for Anemia Associated with Chronic Renal Failure:
Chronic Kidney Disease (CKD) Patients Not on Dialysis:- Initial dose: 0.45 mcg/kg IV or subcutaneously once every 4 weeks as appropriate
- Comments: Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
- Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate
- Comments: Initiate treatment when hemoglobin is less than 10 g/dL. IV route is recommended for patients on hemodialysis.
Usual Adult Dose for Anemia Associated with Chemotherapy:
- Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeks
- Duration of therapy: Until completion of chemotherapy course
- Comments: Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned. Use the lowest dose necessary to avoid RBC transfusions.
- Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.
Side effectsView
Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism; Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with cancer; Hypertension; Seizures; Serious allergic reaction; Severe Cutaneous Reactions
ContraindicationsView
Darbepoetin is contraindicated in patients with:
- Uncontrolled hypertension
- Pure red cell aplasia (PRCA) that begins after treatment with Darbepoetin or other erythropoietin protein drugs
- Serious allergic reactions to Darbepoetin
PrecautionsView
Pregnancy and lactation, children. Hypertension; history of seizures; hepatic impairment; sickle cell anaemia; sudden stabing migraine-like pain (warning sign of hypotensive crisis); exclude other causes of anaemia; ischaemic vascular disease; thrombocytosis; epilepsy; malignant disease; increase in heparin dose may be needed; increased risk of thrombosis when used for anaemia before orthopedic surgery; CV disease including recent MI/cerebrovascular accident. Monitor haemoglobin, BP and electrolytes; platelet count for 1st 8 wk.
InteractionsView
Antagonism of hypotensive effect and increased risk of hyperkalemia with ACE inhibitors and angiotensin II receptor antagonists. Ethanol.
Pregnancy & lactationView
Pregnancy Category C. It is not known whether Darbepoetin Alfa is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Darbepoetin Alfa is administered to a nursing woman.
Pediatric usageView
Pediatric Use:
- Pediatric Patients With CKD: Darbepoetin safety and efficacy were similar between adults and pediatric patients with CKD when Darbepoetin was used for initial treatment of anemia or patients were transitioned from treatment with epoetin alfa to Darbepoetin
- Pediatric Patients With Cancer: The safety and efficacy of Darbepoetin in pediatric patients with cancer have not been established.
Overdose effectsView
Darbepoetin overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Darbepoetin dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs
StorageView
Store at 2°C to 8°C. Do not freeze. Do not shake. Protect from light; store Darbepoetin Alfa in the carton until use. Do not use Darbepoetin Alfa that has been shaken or frozen.
Darbetin
Darbepoetin Alfa
Darbetin
Darbepoetin Alfa
Indications
Anaemia
Indication detailsView
Anemia Due To Chronic Kidney Disease: Darbepoetin Alfa is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Therapeutic classView
Haematopoietic Agents
PharmacologyView
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Erythropoietin interacts with progenitor stem cells to increase red cell production. Binding of erythropoietin to the erythropoietin receptor leads to receptor dimerization, which facilitates activation of JAK-STAT signaling pathways within the cytosol. Activated STAT (signal transducers and activators of transcription) proteins are then translocated to the nucleus where they serve as transcription factors which regulate the activation of specific genes involved in cell division or differentiation.
DosageView
Usual Adult Dose for Anemia Associated with Chronic Renal Failure:
Chronic Kidney Disease (CKD) Patients Not on Dialysis:- Initial dose: 0.45 mcg/kg IV or subcutaneously once every 4 weeks as appropriate
- Comments: Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
- Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate
- Comments: Initiate treatment when hemoglobin is less than 10 g/dL. IV route is recommended for patients on hemodialysis.
Usual Adult Dose for Anemia Associated with Chemotherapy:
- Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeks
- Duration of therapy: Until completion of chemotherapy course
- Comments: Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned. Use the lowest dose necessary to avoid RBC transfusions.
- Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.
Side effectsView
Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism; Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with cancer; Hypertension; Seizures; Serious allergic reaction; Severe Cutaneous Reactions
ContraindicationsView
Darbepoetin is contraindicated in patients with:
- Uncontrolled hypertension
- Pure red cell aplasia (PRCA) that begins after treatment with Darbepoetin or other erythropoietin protein drugs
- Serious allergic reactions to Darbepoetin
PrecautionsView
Pregnancy and lactation, children. Hypertension; history of seizures; hepatic impairment; sickle cell anaemia; sudden stabing migraine-like pain (warning sign of hypotensive crisis); exclude other causes of anaemia; ischaemic vascular disease; thrombocytosis; epilepsy; malignant disease; increase in heparin dose may be needed; increased risk of thrombosis when used for anaemia before orthopedic surgery; CV disease including recent MI/cerebrovascular accident. Monitor haemoglobin, BP and electrolytes; platelet count for 1st 8 wk.
InteractionsView
Antagonism of hypotensive effect and increased risk of hyperkalemia with ACE inhibitors and angiotensin II receptor antagonists. Ethanol.
Pregnancy & lactationView
Pregnancy Category C. It is not known whether Darbepoetin Alfa is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Darbepoetin Alfa is administered to a nursing woman.
Pediatric usageView
Pediatric Use:
- Pediatric Patients With CKD: Darbepoetin safety and efficacy were similar between adults and pediatric patients with CKD when Darbepoetin was used for initial treatment of anemia or patients were transitioned from treatment with epoetin alfa to Darbepoetin
- Pediatric Patients With Cancer: The safety and efficacy of Darbepoetin in pediatric patients with cancer have not been established.
Overdose effectsView
Darbepoetin overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Darbepoetin dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs
StorageView
Store at 2°C to 8°C. Do not freeze. Do not shake. Protect from light; store Darbepoetin Alfa in the carton until use. Do not use Darbepoetin Alfa that has been shaken or frozen.
Darbetin
Darbepoetin Alfa
Darbetin
Darbepoetin Alfa
Indications
Anaemia
Indication detailsView
Anemia Due To Chronic Kidney Disease: Darbepoetin Alfa is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Therapeutic classView
Haematopoietic Agents
PharmacologyView
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Erythropoietin interacts with progenitor stem cells to increase red cell production. Binding of erythropoietin to the erythropoietin receptor leads to receptor dimerization, which facilitates activation of JAK-STAT signaling pathways within the cytosol. Activated STAT (signal transducers and activators of transcription) proteins are then translocated to the nucleus where they serve as transcription factors which regulate the activation of specific genes involved in cell division or differentiation.
DosageView
Usual Adult Dose for Anemia Associated with Chronic Renal Failure:
Chronic Kidney Disease (CKD) Patients Not on Dialysis:- Initial dose: 0.45 mcg/kg IV or subcutaneously once every 4 weeks as appropriate
- Comments: Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
- Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate
- Comments: Initiate treatment when hemoglobin is less than 10 g/dL. IV route is recommended for patients on hemodialysis.
Usual Adult Dose for Anemia Associated with Chemotherapy:
- Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeks
- Duration of therapy: Until completion of chemotherapy course
- Comments: Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned. Use the lowest dose necessary to avoid RBC transfusions.
- Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.
Side effectsView
Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism; Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with cancer; Hypertension; Seizures; Serious allergic reaction; Severe Cutaneous Reactions
ContraindicationsView
Darbepoetin is contraindicated in patients with:
- Uncontrolled hypertension
- Pure red cell aplasia (PRCA) that begins after treatment with Darbepoetin or other erythropoietin protein drugs
- Serious allergic reactions to Darbepoetin
PrecautionsView
Pregnancy and lactation, children. Hypertension; history of seizures; hepatic impairment; sickle cell anaemia; sudden stabing migraine-like pain (warning sign of hypotensive crisis); exclude other causes of anaemia; ischaemic vascular disease; thrombocytosis; epilepsy; malignant disease; increase in heparin dose may be needed; increased risk of thrombosis when used for anaemia before orthopedic surgery; CV disease including recent MI/cerebrovascular accident. Monitor haemoglobin, BP and electrolytes; platelet count for 1st 8 wk.
InteractionsView
Antagonism of hypotensive effect and increased risk of hyperkalemia with ACE inhibitors and angiotensin II receptor antagonists. Ethanol.
Pregnancy & lactationView
Pregnancy Category C. It is not known whether Darbepoetin Alfa is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Darbepoetin Alfa is administered to a nursing woman.
Pediatric usageView
Pediatric Use:
- Pediatric Patients With CKD: Darbepoetin safety and efficacy were similar between adults and pediatric patients with CKD when Darbepoetin was used for initial treatment of anemia or patients were transitioned from treatment with epoetin alfa to Darbepoetin
- Pediatric Patients With Cancer: The safety and efficacy of Darbepoetin in pediatric patients with cancer have not been established.
Overdose effectsView
Darbepoetin overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Darbepoetin dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs
StorageView
Store at 2°C to 8°C. Do not freeze. Do not shake. Protect from light; store Darbepoetin Alfa in the carton until use. Do not use Darbepoetin Alfa that has been shaken or frozen.
Darbetin
Darbepoetin Alfa
Darbetin
Darbepoetin Alfa
Indications
Anaemia
Indication detailsView
Anemia Due To Chronic Kidney Disease: Darbepoetin Alfa is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Therapeutic classView
Haematopoietic Agents
PharmacologyView
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Erythropoietin interacts with progenitor stem cells to increase red cell production. Binding of erythropoietin to the erythropoietin receptor leads to receptor dimerization, which facilitates activation of JAK-STAT signaling pathways within the cytosol. Activated STAT (signal transducers and activators of transcription) proteins are then translocated to the nucleus where they serve as transcription factors which regulate the activation of specific genes involved in cell division or differentiation.
DosageView
Usual Adult Dose for Anemia Associated with Chronic Renal Failure:
Chronic Kidney Disease (CKD) Patients Not on Dialysis:- Initial dose: 0.45 mcg/kg IV or subcutaneously once every 4 weeks as appropriate
- Comments: Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
- Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate
- Comments: Initiate treatment when hemoglobin is less than 10 g/dL. IV route is recommended for patients on hemodialysis.
Usual Adult Dose for Anemia Associated with Chemotherapy:
- Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeks
- Duration of therapy: Until completion of chemotherapy course
- Comments: Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned. Use the lowest dose necessary to avoid RBC transfusions.
- Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.
Side effectsView
Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism; Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with cancer; Hypertension; Seizures; Serious allergic reaction; Severe Cutaneous Reactions
ContraindicationsView
Darbepoetin is contraindicated in patients with:
- Uncontrolled hypertension
- Pure red cell aplasia (PRCA) that begins after treatment with Darbepoetin or other erythropoietin protein drugs
- Serious allergic reactions to Darbepoetin
PrecautionsView
Pregnancy and lactation, children. Hypertension; history of seizures; hepatic impairment; sickle cell anaemia; sudden stabing migraine-like pain (warning sign of hypotensive crisis); exclude other causes of anaemia; ischaemic vascular disease; thrombocytosis; epilepsy; malignant disease; increase in heparin dose may be needed; increased risk of thrombosis when used for anaemia before orthopedic surgery; CV disease including recent MI/cerebrovascular accident. Monitor haemoglobin, BP and electrolytes; platelet count for 1st 8 wk.
InteractionsView
Antagonism of hypotensive effect and increased risk of hyperkalemia with ACE inhibitors and angiotensin II receptor antagonists. Ethanol.
Pregnancy & lactationView
Pregnancy Category C. It is not known whether Darbepoetin Alfa is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Darbepoetin Alfa is administered to a nursing woman.
Pediatric usageView
Pediatric Use:
- Pediatric Patients With CKD: Darbepoetin safety and efficacy were similar between adults and pediatric patients with CKD when Darbepoetin was used for initial treatment of anemia or patients were transitioned from treatment with epoetin alfa to Darbepoetin
- Pediatric Patients With Cancer: The safety and efficacy of Darbepoetin in pediatric patients with cancer have not been established.
Overdose effectsView
Darbepoetin overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Darbepoetin dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs
StorageView
Store at 2°C to 8°C. Do not freeze. Do not shake. Protect from light; store Darbepoetin Alfa in the carton until use. Do not use Darbepoetin Alfa that has been shaken or frozen.