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Egolix

Elagolix

Tablet 200 mg Allopathic Gonadotropin-releasing hormone (GnRH) antagonist

Indications

Endometriosis

Indication detailsView

Elagolix is indicated for the management of moderate to severe pain associated with endometriosis.

Therapeutic classView

Gonadotropin-releasing hormone (GnRH) antagonist

PharmacologyView

Endometriosis develops when tissue that is similar to the kind that is normally located in the uterus starts to grow outside of the uterus. Such growth leads to various symptoms like pain during periods, pelvic pain between periods, and pain during sexual intercourse. The growths themselves are referred to as lesions and frequently develop on the ovaries, fallopian tubes, and other areas around the uterus, including the bowel or bladder. The growth of these lesions is dependent upon the estrogen hormone.

Elagolix is an orally-administered, nonpeptide small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist that inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland Label. Administration of elagolix results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of the ovarian sex hormones, estradiol and progesterone.

DosageView

Exclude pregnancy before starting Elagolix or start Elagolix within 7 days from the onset of menses. Take Elagolix at approximately the same time each day, with or without food.

Initiate treatment with Elagolix 150 mg once daily-

Maximum Treatment Duration: 24 months
Coexisting Condition: None

Consider initiating treatment with Elagolix 200 mg twice daily-

Maximum Treatment Duration: 6 months
Coexisting Condition: Dyspareunia

Initiate treatment with Elagolix 150 mg once daily. Use of 200 mg twice daily is not recommended-

Maximum Treatment Duration: 6 months
Coexisting Condition: Moderate hepatic impairment (Child-Pugh Class B)

Side effectsView

Most common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions and mood changes.

ContraindicationsView

Elagolix is contraindicated in women:

Who are pregnant
Exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss.
With known osteoporosis because of the risk of further bone loss
With severe hepatic impairment because of the risk of bone loss
With concomitant use of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors (e.g., cyclosporine and gemfibrozil)

PrecautionsView

Bone Loss: Dose- and duration-dependent decreases in bone mineral density (BMD) that may not be completely reversible. Assess BMD in women with additional risk factors for bone loss
Reduced Ability to Recognize Pregnancy: Elagolix may alter menstrual bleeding, which may reduce the ability to recognize pregnancy. Perform testing if pregnancy is suspected. Discontinue if pregnancy is confirmed
Suicidal Ideation and Mood Disorders: Advise patients to seek medical attention for suicidal ideation, suicidal behavior, new onset or worsening depression, anxiety, or other mood changes
Hepatic Transaminase Elevations: Dose-dependent elevations in serum alanine aminotransferase (ALT). Counsel patients on signs and symptoms of liver injury
Potential for Reduced Efficacy with Estrogen-Containing Contraceptives: Use non-hormonal contraception during treatment and for one week after discontinuing Elagolix.

InteractionsView

May potentiate P-gp substrates (eg. Digoxin), CYP2C19 substrates (eg. Dose limit of Omeprazole is upto 40mg daily). May antagonize CYP3A substrates. Antagonizes oral Midazolam, Rosuvastatin; consider increasing their doses. Maybe antagonized by CYP3A inducers. Reduces efcacy with estrogen-containing contraceptives.

Pregnancy & lactationView

Exposure to Elagolix early in pregnancy may increase the risk of early pregnancy loss. Use of Elagolix is contraindicated in pregnant women. Discontinue Elagolix if pregnancy occurs during treatment. The limited human data with the use of Elagolix in pregnant women are insufficient to determine whether there is a risk for major birth defects or miscarriage. Although two cases of congenital malformations were reported in clinical trials with Elagolix, no pattern was identified and miscarriages were reported at a similar incidence across treatment groups. There is no information on the presence of elagolix or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production.

There are no adequate animal data on the excretion of Elagolix in milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Elagolix and any potential adverse effects on the breastfed child from Elagolix.

Pediatric usageView

No dose adjustment of Elagolix is required in women with any degree of renal impairment or end-stage renal disease (including women on dialysis)
No dosage adjustment of Elagolix is required in women with mild hepatic impairment.
Safety and effectiveness of Elagolix in patients less than 18 years of age have not been established.

Overdose effectsView

In case of overdose, patients should be monitored for any signs or symptoms of adverse reactions and initiate appropriate symptomatic treatment, as needed.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Egut

Domperidone Maleate

Tablet 10 mg Allopathic Motility Stimulants

Indications

Vomiting

Indication detailsView

Dyspeptic symptom complex, often associated with delayed gastric emptying, gastroesophageal reflux and esophagitis:

Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
Eructation, flatulence, early satiety
Nausea and vomiting
Heartburn with or without regurgitations of gastric contents in the mouth
Non-ulcer dyspepsia

Acute nausea and vomiting of the functional, organic, infectious, dietetic origin or induced by radiotherapy or drug therapy or induced in migraine.

Parkinson's disease: In dopamine-agonist induced nausea and vomiting.

Radiological studies: Speeding barium transit in follow-through radiological studies.

Therapeutic classView

Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs

PharmacologyView

Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal tract. Due to its weak penetration across the blood-brain barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore, excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.

DosageView

Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.

The usual recommended oral dose of Domperidone is as follows:

Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.

In dyspeptic symptom:

Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.

In acute and sub-acute conditions (mainly in acute nausea and vomiting):

Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).

By rectum in suppositories:

Adults (including elderly): 30-60 mg every 4-8 hours.
Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
The maximum period of treatment is 12 weeks.

Side effectsView

Domperidone may produce hyperprolactinemia (1.3%).This may result in galactorrhea, breast enlargement, and soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.

ContraindicationsView

Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).

PrecautionsView

Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.

InteractionsView

Domperidone may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Domperidone on Gl function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.

Pregnancy & lactationView

The safety of domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated the teratogenic effect in the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.

Overdose effectsView

There are no reported cases of overdose.

StorageView

Store below 30°C, Protected from light & moisture. Keep out of children's reach.

Egut

Domperidone Maleate

Oral Suspension 5 mg/5 ml Allopathic Motility Stimulants

Indications

Vomiting

Indication detailsView

Dyspeptic symptom complex, often associated with delayed gastric emptying, gastroesophageal reflux and esophagitis:

Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
Eructation, flatulence, early satiety
Nausea and vomiting
Heartburn with or without regurgitations of gastric contents in the mouth
Non-ulcer dyspepsia

Acute nausea and vomiting of the functional, organic, infectious, dietetic origin or induced by radiotherapy or drug therapy or induced in migraine.

Parkinson's disease: In dopamine-agonist induced nausea and vomiting.

Radiological studies: Speeding barium transit in follow-through radiological studies.

Therapeutic classView

Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs

PharmacologyView

Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal tract. Due to its weak penetration across the blood-brain barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore, excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.

DosageView

Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.

The usual recommended oral dose of Domperidone is as follows:

Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.

In dyspeptic symptom:

Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.

In acute and sub-acute conditions (mainly in acute nausea and vomiting):

Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).

By rectum in suppositories:

Adults (including elderly): 30-60 mg every 4-8 hours.
Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
The maximum period of treatment is 12 weeks.

Side effectsView

Domperidone may produce hyperprolactinemia (1.3%).This may result in galactorrhea, breast enlargement, and soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.

ContraindicationsView

Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).

PrecautionsView

Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.

InteractionsView

Domperidone may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Domperidone on Gl function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.

Pregnancy & lactationView

The safety of domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated the teratogenic effect in the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.

Overdose effectsView

There are no reported cases of overdose.

StorageView

Store below 30°C, Protected from light & moisture. Keep out of children's reach.

Ejalong

Dapoxetine Hydrochloride

Tablet 60 mg Allopathic Drugs for Erectile Dysfunction

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.

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

Ejalong

Dapoxetine Hydrochloride

Tablet 30 mg Allopathic Drugs for Erectile Dysfunction

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.

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

Eket

Ketorolac Tromethamine

Tablet 10 mg Allopathic Drugs used for Rheumatoid Arthritis

Indications

Soft tissue inflammation

Indication detailsView

Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.

Therapeutic classView

Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics

PharmacologyView

Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.

DosageView

Tablet-

Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.

Injection-

Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.

Single-Dose Treatment-
IM Dosing (Adult):

Patients <65 years of age: One dose of 60 mg.
Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.

IV Dosing (Adult):

Patients <65 years of age: One dose of 30 mg.
Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.

IV or IM Dosing (2 to 16 years of age):

IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.

Multiple-Dose Treatment (IV or IM)-

Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.

Side effectsView

Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.

ContraindicationsView

Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.

PrecautionsView

Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.

InteractionsView

Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.

Pregnancy & lactationView

US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Eket

Ketorolac Tromethamine

IM/IV Injection 30 mg/ml Allopathic Drugs used for Rheumatoid Arthritis

Indications

Soft tissue inflammation

Indication detailsView

Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.

Therapeutic classView

Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics

PharmacologyView

Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.

DosageView

Tablet-

Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.

Injection-

Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.

Single-Dose Treatment-
IM Dosing (Adult):

Patients <65 years of age: One dose of 60 mg.
Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.

IV Dosing (Adult):

Patients <65 years of age: One dose of 30 mg.
Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.

IV or IM Dosing (2 to 16 years of age):

IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.

Multiple-Dose Treatment (IV or IM)-

Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.

Side effectsView

Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.

ContraindicationsView

Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.

PrecautionsView

Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.

InteractionsView

Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.

Pregnancy & lactationView

US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Ekzina

Clobetasol Propionate + Salicylic Acid

Ointment 0.05%+3% Allopathic Clobetasol / Clobetasone & Combined Preparations

Indications

Warts

Indication detailsView

This ointment is indicated for the relief of the inflammatory manifestations of hyperkeratotic and dry corticosteroid responsive dermatoses such as, psoriasis, chronic atopic dermatitis, neurodermatitis (licehen Simplex, Chronicus), lichen planus, eczema (including nummular eczema, hand eczema, eczematous dermatitis), seborrheic dermatitis of the scalp, ichthyosis vulgaris and other ichthyotic conditions.

Therapeutic classView

Clobetasol / Clobetasone & Combined Preparations

PharmacologyView

Clobetasol Propionate high potency corticosteroid. Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; and reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation.

Salicylic acid has a potent keratolytic action and a slight antiseptic action when applied topically. It softens and destroys the stratum corneum by increasing endogenous hydration which causes the horny layer of the skin to swell, soften, and then desquamate. At high concentrations, salicylic acid has a caustic effect. It also possesses weak antifungal and antibacterial activity.

DosageView

Adult: Apply a thin layer of this ointment to the affected skin areas twice daily and rub in gently & completely. For some patients, adequate maintenance therapy may be achieved with less frequent application. As with other higher active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. It should not be used with occlusive dressing. Treatment beyond 2 consecutive weeks is not exceeding 50 gm/week because of the potential for the drug to suppress the hypothalamic pituitary adrenal axis.

Children: Use in pediatric patients under 12 years of age is not recommended.

AdministrationView

For external use only.

Side effectsView

As with other topical corticosteroids, prolonged use of large amounts of Clobetasol Propionate or treatment of extensive areas can result in sufficient systemic absorption to produce the features of hypercortisolism. This effect is more likely to occur in infants and children, and if occlusive dressings are used. Local atrophy may occur after prolonged treatment. In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the diseases. Clobetasol Propionate is usually well tolerated, but if signs of hypersensitivity appear, application should be stopped immediately. Possible sensitivity reactions, drying and irritation when using Salicylic Acid.

ContraindicationsView

ClobetasolPropionatev is contraindicated in patients with hypersensitivity to Clobetasol Propionate. This preparation is contraindicated also in the treatment of primary infected bacterial or fungal skin lesions if no anti-infective agent is used simultaneously, in primary cutaneous viral infections (i.e., herpes simplex, vaccinia and varicella) and in tuberculous skin lesions. Clobetasol Propionate is also contraindicated in dermatoses in children under one year of age, including dermatitis and diaper eruptions. Salicylic Acid is contraindicated in patients displaying salicylate hyersensitivity, or sensitivity to any other ingredient in the preparation.

PrecautionsView

Not for prolonged use in high concentrations and on large areas of the body. Impaired peripheral circulation or diabetes. Avoid broken skin, mouth, eyes, mucous membranes and anogenital region.

InteractionsView

There has been no report of interaction with Clobetasol Propionate ointment and cream. There are no known interactions of Salicylic Acid when used as indicated. However, topical salicylic acid may increase the absorption of other topically applied medicines. Concomitant use of Salicylic Acid Ointment and other topical medicines on the same area of skin should therefore be avoided.

Pregnancy & lactationView

Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. The relevance of this finding to human beings has not been established. The safe use of Clobetasol Propionate during lactation has not been established. However, the administration of Clobetasol Propionate during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. Drugs of this class should not be used extensively in pregnant patients in large amounts or for prolonged periods of time. Whilst there are no known contra-indications to the use of Salicylic Acid ointment during pregnancy and lactation, the safety has not been established. Salicylic Acid ointment shold therefore be used with caution.

Overdose effectsView

Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercortisolism may appear and in this situation topical steroids should be discontinued gradually. However, because of the risk of acute adrenal suppression this should be done under medical supervision. Symptoms osslystemic salicylate poisoning (tinnitus, dizziness and deafness) have been reported after the application of Salicylic Acid to large areas of skin and for prolonged periods. Salicylism may also occur in the unlikely event of large quantities being ingested. Salicylism is ullikely to occur if Salicylic Acid ointment is used as indicated. Salicylate poisoining is usually associated with plasma concentrations >350 mg/L. Most adult deaths occur in patients whose concentrations exceed 700 ml/L. Single doses less than 100 mg/kg are unlikely to cause serious poisoning.

StorageView

Store in a cool and dry place, protected from light.

Eladin

Loratadine

Tablet 10 mg Allopathic Non-sedating antihistamines

Indications

Urticaria

Indication detailsView

Loratadine tablet provides fast, effective relief from the symptoms of seasonal allergic rhinitis, perennial allergic rhinitis and skin allergies including chronic urticaria. It is also effective in alleviating symptoms of allergic rhinitis such as sneezing, nasal discharge, itching, ocular itching and burning. Nasal and ocular sign and symptoms are relieved rapidly after oral administration. Loratadine tablet is also indicated in idiopathic urticaria. In children over 2 years Loratadine tablet is indicated for the symptomatic relief of seasonal allergic rhinitis and allergic skin conditions such as urticaria, nettlerash.

Therapeutic classView

Non-sedating antihistamines

PharmacologyView

This tablet is a preparation of Loratadine. Loratadine is a non-sedative histamine Hr receptor antagonist with antiallergic properties. Loratadine is a long-acting tricyclic antihistamine with selective peripheral Hi-receptor antagonistic activity and no central sedative or anticholinergic effect. It is rapidly effective and long-lasting, allowing once-a-day administration.

DosageView

Adults and children over 12 years of age: One Loratadine tablet once daily. It is usually administered in the morning or when symptoms require treatment.

Children 2-12 years: Body weight over 30 kg: one Loratadine tablet once daily, below 30 kg: half Loratadine tablet once daily.

Below 2 years of age: Loratadine tablet is not recommended for use below 2 years of age since safety and efficacy has not been established.

Side effectsView

During controlled clinical studies the incidence of adverse events, including sedation and anticholinergic effects observed with 10 mg Loratadine was comparable to that observed with placebo. Studies on the effect of Loratadine on actual driving performance, and on tests of cognitive and psychomotor functioning have shown it to be comparable to placebo.

ContraindicationsView

Loratadine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.

PrecautionsView

Caution should be taken in patients with liver impairment or renal insufficiency (eGFR <30 ml/min).

InteractionsView

There are no reports of potentially hazardous interactions with other drugs. In contrast to many other histamine H1 receptor antagonists, Loratadine has no potentiating effects when administered concurrently with alcohol, as measured by psychomotor performance studies. Concomitant therapy with drugs that inhibit or are metabolized by hepatic cytochromes P450 3A4 and 2D6 may elevate plasma concentrations of either drug and this mayifesult in adverse effects. Cimetidine inhibits both enzymes while erythromycin or ketoconazole inhibits P450 3A4. These drugs increase loratadine serum concentrations but no adverse effects are reported.

Pregnancy & lactationView

There is no experience of the use of Loratadine in human pregnancy. Therefore its use during pregnancy is not advisable. Loratadine is excreted in breast milk in a very small amount. So nursing mothers are advised not to take the drug.

Overdose effectsView

In adults somnolence, tachycardia and headache have been reported with overdose greater than 10 mg. Extrapyramidal signs and palpitations have been reported in children with overdoses of greater than 10 mg. In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. It would seem reasonable to treat patients presenting early after large overdoses with oral activated charcoal. The conscious patients may be induced to vomit or gastric lavage may be performed.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Eladin

Loratadine

Oral Suspension 5 mg/5 ml Allopathic Non-sedating antihistamines

Indications

Urticaria

Indication detailsView

Loratadine tablet provides fast, effective relief from the symptoms of seasonal allergic rhinitis, perennial allergic rhinitis and skin allergies including chronic urticaria. It is also effective in alleviating symptoms of allergic rhinitis such as sneezing, nasal discharge, itching, ocular itching and burning. Nasal and ocular sign and symptoms are relieved rapidly after oral administration. Loratadine tablet is also indicated in idiopathic urticaria. In children over 2 years Loratadine tablet is indicated for the symptomatic relief of seasonal allergic rhinitis and allergic skin conditions such as urticaria, nettlerash.

Therapeutic classView

Non-sedating antihistamines

PharmacologyView

This tablet is a preparation of Loratadine. Loratadine is a non-sedative histamine Hr receptor antagonist with antiallergic properties. Loratadine is a long-acting tricyclic antihistamine with selective peripheral Hi-receptor antagonistic activity and no central sedative or anticholinergic effect. It is rapidly effective and long-lasting, allowing once-a-day administration.

DosageView

Adults and children over 12 years of age: One Loratadine tablet once daily. It is usually administered in the morning or when symptoms require treatment.

Children 2-12 years: Body weight over 30 kg: one Loratadine tablet once daily, below 30 kg: half Loratadine tablet once daily.

Below 2 years of age: Loratadine tablet is not recommended for use below 2 years of age since safety and efficacy has not been established.

Side effectsView

During controlled clinical studies the incidence of adverse events, including sedation and anticholinergic effects observed with 10 mg Loratadine was comparable to that observed with placebo. Studies on the effect of Loratadine on actual driving performance, and on tests of cognitive and psychomotor functioning have shown it to be comparable to placebo.

ContraindicationsView

Loratadine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.

PrecautionsView

Caution should be taken in patients with liver impairment or renal insufficiency (eGFR <30 ml/min).

InteractionsView

There are no reports of potentially hazardous interactions with other drugs. In contrast to many other histamine H1 receptor antagonists, Loratadine has no potentiating effects when administered concurrently with alcohol, as measured by psychomotor performance studies. Concomitant therapy with drugs that inhibit or are metabolized by hepatic cytochromes P450 3A4 and 2D6 may elevate plasma concentrations of either drug and this mayifesult in adverse effects. Cimetidine inhibits both enzymes while erythromycin or ketoconazole inhibits P450 3A4. These drugs increase loratadine serum concentrations but no adverse effects are reported.

Pregnancy & lactationView

There is no experience of the use of Loratadine in human pregnancy. Therefore its use during pregnancy is not advisable. Loratadine is excreted in breast milk in a very small amount. So nursing mothers are advised not to take the drug.

Overdose effectsView

In adults somnolence, tachycardia and headache have been reported with overdose greater than 10 mg. Extrapyramidal signs and palpitations have been reported in children with overdoses of greater than 10 mg. In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. It would seem reasonable to treat patients presenting early after large overdoses with oral activated charcoal. The conscious patients may be induced to vomit or gastric lavage may be performed.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Elagox

Elagolix

Tablet 150 mg Allopathic Gonadotropin-releasing hormone (GnRH) antagonist

Indications

Endometriosis

Indication detailsView

Elagolix is indicated for the management of moderate to severe pain associated with endometriosis.

Therapeutic classView

Gonadotropin-releasing hormone (GnRH) antagonist

PharmacologyView

Endometriosis develops when tissue that is similar to the kind that is normally located in the uterus starts to grow outside of the uterus. Such growth leads to various symptoms like pain during periods, pelvic pain between periods, and pain during sexual intercourse. The growths themselves are referred to as lesions and frequently develop on the ovaries, fallopian tubes, and other areas around the uterus, including the bowel or bladder. The growth of these lesions is dependent upon the estrogen hormone.

Elagolix is an orally-administered, nonpeptide small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist that inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland Label. Administration of elagolix results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of the ovarian sex hormones, estradiol and progesterone.

DosageView

Exclude pregnancy before starting Elagolix or start Elagolix within 7 days from the onset of menses. Take Elagolix at approximately the same time each day, with or without food.

Initiate treatment with Elagolix 150 mg once daily-

Maximum Treatment Duration: 24 months
Coexisting Condition: None

Consider initiating treatment with Elagolix 200 mg twice daily-

Maximum Treatment Duration: 6 months
Coexisting Condition: Dyspareunia

Initiate treatment with Elagolix 150 mg once daily. Use of 200 mg twice daily is not recommended-

Maximum Treatment Duration: 6 months
Coexisting Condition: Moderate hepatic impairment (Child-Pugh Class B)

Side effectsView

Most common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions and mood changes.

ContraindicationsView

Elagolix is contraindicated in women:

Who are pregnant
Exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss.
With known osteoporosis because of the risk of further bone loss
With severe hepatic impairment because of the risk of bone loss
With concomitant use of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors (e.g., cyclosporine and gemfibrozil)

PrecautionsView

Bone Loss: Dose- and duration-dependent decreases in bone mineral density (BMD) that may not be completely reversible. Assess BMD in women with additional risk factors for bone loss
Reduced Ability to Recognize Pregnancy: Elagolix may alter menstrual bleeding, which may reduce the ability to recognize pregnancy. Perform testing if pregnancy is suspected. Discontinue if pregnancy is confirmed
Suicidal Ideation and Mood Disorders: Advise patients to seek medical attention for suicidal ideation, suicidal behavior, new onset or worsening depression, anxiety, or other mood changes
Hepatic Transaminase Elevations: Dose-dependent elevations in serum alanine aminotransferase (ALT). Counsel patients on signs and symptoms of liver injury
Potential for Reduced Efficacy with Estrogen-Containing Contraceptives: Use non-hormonal contraception during treatment and for one week after discontinuing Elagolix.

InteractionsView

May potentiate P-gp substrates (eg. Digoxin), CYP2C19 substrates (eg. Dose limit of Omeprazole is upto 40mg daily). May antagonize CYP3A substrates. Antagonizes oral Midazolam, Rosuvastatin; consider increasing their doses. Maybe antagonized by CYP3A inducers. Reduces efcacy with estrogen-containing contraceptives.

Pregnancy & lactationView

Exposure to Elagolix early in pregnancy may increase the risk of early pregnancy loss. Use of Elagolix is contraindicated in pregnant women. Discontinue Elagolix if pregnancy occurs during treatment. The limited human data with the use of Elagolix in pregnant women are insufficient to determine whether there is a risk for major birth defects or miscarriage. Although two cases of congenital malformations were reported in clinical trials with Elagolix, no pattern was identified and miscarriages were reported at a similar incidence across treatment groups. There is no information on the presence of elagolix or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production.

There are no adequate animal data on the excretion of Elagolix in milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Elagolix and any potential adverse effects on the breastfed child from Elagolix.

Pediatric usageView

No dose adjustment of Elagolix is required in women with any degree of renal impairment or end-stage renal disease (including women on dialysis)
No dosage adjustment of Elagolix is required in women with mild hepatic impairment.
Safety and effectiveness of Elagolix in patients less than 18 years of age have not been established.

Overdose effectsView

In case of overdose, patients should be monitored for any signs or symptoms of adverse reactions and initiate appropriate symptomatic treatment, as needed.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Elargen

Bilastine

Tablet 20 mg Allopathic Non-sedating antihistamines

Indications

Urticaria

Indication detailsView

Bilastine is indicated for symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria.

Therapeutic classView

Non-sedating antihistamines

PharmacologyView

Bilastine is a non-sedating, long-acting histamine antagonist with selective peripheral H 1 receptor antagonist affinity and no affinity for muscarinic receptors. Bilastine inhibits histamine-induced wheal and flare skin reactions for 24 hours following single doses.

DosageView

Adults & adolescents (12 years of age and over): 20 mg tablet once daily for symptomatic relief of allergic rhinitis, urticaria and allergic rhinoconjunctivitis. The maximum recommended daily dose is 20 mg Bilastine (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken. 20 mg Bilastine tablet (1 tablet) once daily should be swallowed with water on an empty stomach to achieve optimal exposure to Bilastine.

Children between 6 to 11 years: 10 mg mouth dissolving tablet for the symptomatic relief of allergic rhinitis, allergic rhinoconjunctivitis and urticaria. The Mouth dissolving tablet is for oral use only. It should be placed in the mouth. It will disperse rapidly in saliva and can be easily swallowed. Alternatively, the mouth dissolving tablet can be dispersed in a tea spoon of water before being swallowed by the children. The maximum recommended daily dose for children in between 6 to 11 years is 10 mg Bilastine mouth dissolving tablet (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken.

Children between 2 to 11 years: 4 ml once daily.

Side effectsView

The most commonly reported side effects in clinical trial are headache, dizziness, somnolence and fatigue. These adverse events occurred with a comparable frequency in patients receiving placebo.

ContraindicationsView

Bilastine is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients of the tablet.

PrecautionsView

Co-administration of Bilastine and P-glycoprotein inhibitors (e.g. Ketoconazole, Erythromycin, Cyclosporine, Ritonavir or Diltiazem) should be avoided in patients with moderate or severe renal impairment.

InteractionsView

Concomitant intake of Bilastine and Ketoconazole or Erythromycin or Diltiazem increased C max of Bilastine. The psychomotor performance after concomitant intake of alcohol and Bilastine was similar to that observed after intake of alcohol and placebo. Concomitant intake of Bilastine and Lorazepam 3 mg for 8 days did not potentiate the depressant CNS effects of Lorazepam.

Pregnancy & lactationView

There are no or limited amount of data from the use of Bilastine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of Bilastine during pregnancy. The excretion of Bilastine in milk has not been studied in humans. A decision must be made taking into account the benefit of breast-feeding for the child and the benefit of Bilastine therapy for the mother.

Pediatric usageView

Efficacy and safety of Bilastine in children under 2 years of age have not been established and there is little clinical experience in children aged 2 to 5 years, therefore Bilastine should not be used in these age groups.

Overdose effectsView

In clinical trials, after administration of Bilastine at doses 10 to 11 times the therapeutic dose (220 mg as single dose; or 200 mg/day for 7 days) frequency of treatment-emergent adverse events was two times higher than with placebo. The adverse reactions most frequently reported were dizziness, headache and nausea. No serious adverse events and no significant prolongation in the QTc interval were reported.

StorageView

Keep below 30°C temperature, protected from light and moisture. Keep out of reach of children.

Elazol

Voriconazole

Tablet 200 mg Allopathic Other Antifungal preparations

Indications

Scedosporiosis and fusariosis

Indication detailsView

Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-

Invasive aspergillosis
Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
Esophageal candidiasis
Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
Patients intolerant of, or refractory to other therapy.

Therapeutic classView

Other Antifungal preparations

PharmacologyView

Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.

DosageView

Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal

At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Injection-
Invasive Aspergillosisd :

Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
Maintenance Dose: 4 mg/kg 12 hourly.

Candidemia in nonneutropenic patients and other deep tissue Candida infections:

Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
Maintenance Dose: 3-4 mg/kg 12 hourly.

Scedosporiosis and Fusariosis:

Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
Maintenance Dose: 4 mg/kg 12 hourly.

Side effectsView

The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.

ContraindicationsView

Known hypersensitivity to Voriconazole or any other components of this drug-

Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy

PrecautionsView

Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.

InteractionsView

CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric usageView

The efficacy to the children under 12 years of age is not established.

Overdose effectsView

There is no data found about overdose of Voriconazole.

ReconstitutionView

Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.

StorageView

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.

Elazol

Voriconazole

Tablet 50 mg Allopathic Other Antifungal preparations

Indications

Scedosporiosis and fusariosis

Indication detailsView

Voriconazole is an azole antifungal medicine. It is indicated for use in patients 12 years of age and older in the treatment of following fungal infections-

Invasive aspergillosis
Candidemia (nonneutropenic) and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds
Esophageal candidiasis
Serious infections caused by Scedosporium apiospermum and Fusarium Species including Fusarium solani
Patients intolerant of, or refractory to other therapy.

Therapeutic classView

Other Antifungal preparations

PharmacologyView

Voriconazole is a triazole antifungal medication used to treat serious fungal infections. Voriconazole binds and inhibits ergosterol synthesis by inhibiting CYP450-dependent 14-alpha sterol demethylase. The inhibition of 14-alpha sterol demethylase results in a depletion of ergosterol in fungal cell membrane.

DosageView

Oral-
Voriconazole tablet and powder for suspension are to be taken at least one hour before or one hour following a meal

At or over 40 kg body weight: Loading dose regimen is 400 mg or 10 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 200 mg or 5 ml twice daily.
Below 40 Kg body weight: Loading dose regimen is 200 mg or 5 ml every 12 hours (for the first 24 hours) and maintenance dose (after first 24 hours) is 100 mg or 2.5 ml twice daily. Or, as directed by the registered physician.

Injection-
Invasive Aspergillosisd :

Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
Maintenance Dose: 4 mg/kg 12 hourly.

Candidemia in nonneutropenic patients and other deep tissue Candida infections:

Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
Maintenance Dose: 3-4 mg/kg 12 hourly.

Scedosporiosis and Fusariosis:

Loading dose: 6 mg/kg 12 hourly for the first 24 hours.
Maintenance Dose: 4 mg/kg 12 hourly.

Side effectsView

The most common side effects are abdominal pain, anemia, blurred vision, headache, chest pain, nausea and diarrhea.

ContraindicationsView

Known hypersensitivity to Voriconazole or any other components of this drug-

Co-administration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions
Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids and St. John's Wort due to risk of loss of efficacy

PrecautionsView

Long term exposure (treatment or prophylaxis) greater than 180 days requires careful assessment of the benefit-risk balance. Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term voriconazole treatment.

InteractionsView

CYP3A4, CYP2C9 and CYP2C19 inhibitors and inducers: Adjust Voriconazole dosage and monitor for adverse reactions or lack of efficacy
Voriconazole may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce doses of these other drugs and monitor for adverse reactions
Increase maintenance oral and intravenous dosage of Voriconazole with co-administration of Phenytoin or Efavirenz

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric usageView

The efficacy to the children under 12 years of age is not established.

Overdose effectsView

There is no data found about overdose of Voriconazole.

ReconstitutionView

Reconstitution Instructions of suspension: Shake the bottle well before adding water to loosen the powder. Add 25 ml of boiled and cooled water to the bottle (5 spoons of a provided spoon). Shake the closed bottle vigorously until powder mixed completely with the water. Store reconstituted suspension between 15°-30° C. Discard suspension 14 days after reconstitution.

StorageView

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light. Store Voriconazole powder for suspension between 2° to 8°C temperature.

Electro-K

Potassium Chloride

Syrup 500 mg/5 ml Allopathic Electrolytes preparations

Indications

Ulcerative colitis

Indication detailsView

Potassium Chloride is indicated in-

Replacement of potassium deficit
Diuretic (Potassium losing)-induced hypokalaemia
Hypokalaemia from renal potassium wasting
Hypokalaemia from gastrointestinal losses
Hypochloraemic alkalosis associated with hypokalaemia

Therapeutic classView

Electrolytes preparations, Oral electrolytes preparations

PharmacologyView

Potassium Chloride is used for the treatment of hypokalaemia and of potassium deficiency states. Potassium ion is the principal intracellular cation of most body tissues. It participates in a number of essential physiological processes, including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle and the maintenance of normal renal function.

DosageView

Oral dose: It should be taken with or after meals with plenty of fluid (water/fruit juice). Typical doses for the prevention of hypokalaemia may be upto 50 mmol (about 37.5 mL) daily by mouth. Oral treatment may be suitable in some cases of hypokalaemia and similar doses to those used for prevention may be adequate in mild potassium deficiency. However, higher doses may be needed in more severe deficiency.

Parenteral dose: Intravenous administration may be required in acute hypokalaemia. One ampoule (10 mL) i.e. 1.5 gm (20 mmol k+) may be added to 500 mL of sodium chloride or glucose intravenous infusion and given slowly over 2 to 3 hours with specialist advice and ECG monitoring in difficult cases. Repeated measurements of potassium are necessary to determine whether further infusions are required and to avoid the development of hyperkalaemia. This is especially liable to occur in renal impairment.

Side effectsView

Excessive administration of potassium leads to development of hyperkalaemia, the symptoms of which include paraesthesia of the extremitis, muscle weakness, paralysis, hypotension, cardiac arrhythmias, heart block and cardiac arrest. Pain or phlebitis may occur during I.V. administration of solutions containing about 30 mmol or more potassium per litre. Nausea, vomiting, diarrhoea and abdominal cramps may occur following oral administration.

ContraindicationsView

Hypersensitivity to potassium administration e.g. hyperkalaemic periodic paralysis, congenital paramyotonia, marked renal failure (even when not yet associated with manifest hyperkalaemia), untreated Addison's disease, hyporeninaemic hypoaldosteronism, acute dehydration, hyperkalaemia and conditions involving extensive cell destruction (e.g. severe burns). In case of metabolic acidosis, the hypokalaemia should be treated not with potassium chloride.

PrecautionsView

It should be administered with caution to patients with renal or adrenocortical insufficiency, cardiac disease, acute dehydration, heat cramps, extensive tissue destruction as occurs with severe burns, or to patients receiving potassium-sparing diuretics. Excessive use of potassium-containing salt substitutes or concurrent administration with potassium supplements may lead to accumulation of potasssium especially in patients with renal insufficiency. Attention should be paid to the concurrent use of other drugs that either contain potassium or have the potential for hyperkalaemia. Treatment should be discontinued if severe nausea, vomiting or abdominal distress develops.

InteractionsView

Combined treatment with the following increase the risk of hyperkalaemia: Angiotensin-converting enzyme inhibitors, cyclosporin, NSAIDs, beta-blockers, heparin, digoxin, potassium-sparing diuretics.

Pregnancy & lactationView

As a general rule, no drugs should be taken during the first three months of pregnancy and the risks & benefits of taking drugs should be carefully considered throughout pregnancy. There are no contraindications to breastfeeding while taking potassium salts.

Pediatric usageView

Use in children: No special precautions are required.

StorageView

Store below 25°C in a dry place, away from light. Keep out of the reach of children.

Electro-K

Potassium Chloride

Tablet 600 mg Allopathic Electrolytes preparations

Indications

Ulcerative colitis

Indication detailsView

Potassium Chloride is indicated in-

Replacement of potassium deficit
Diuretic (Potassium losing)-induced hypokalaemia
Hypokalaemia from renal potassium wasting
Hypokalaemia from gastrointestinal losses
Hypochloraemic alkalosis associated with hypokalaemia

Therapeutic classView

Electrolytes preparations, Oral electrolytes preparations

PharmacologyView

Potassium Chloride is used for the treatment of hypokalaemia and of potassium deficiency states. Potassium ion is the principal intracellular cation of most body tissues. It participates in a number of essential physiological processes, including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle and the maintenance of normal renal function.

DosageView

Oral dose: It should be taken with or after meals with plenty of fluid (water/fruit juice). Typical doses for the prevention of hypokalaemia may be upto 50 mmol (about 37.5 mL) daily by mouth. Oral treatment may be suitable in some cases of hypokalaemia and similar doses to those used for prevention may be adequate in mild potassium deficiency. However, higher doses may be needed in more severe deficiency.

Parenteral dose: Intravenous administration may be required in acute hypokalaemia. One ampoule (10 mL) i.e. 1.5 gm (20 mmol k+) may be added to 500 mL of sodium chloride or glucose intravenous infusion and given slowly over 2 to 3 hours with specialist advice and ECG monitoring in difficult cases. Repeated measurements of potassium are necessary to determine whether further infusions are required and to avoid the development of hyperkalaemia. This is especially liable to occur in renal impairment.

Side effectsView

Excessive administration of potassium leads to development of hyperkalaemia, the symptoms of which include paraesthesia of the extremitis, muscle weakness, paralysis, hypotension, cardiac arrhythmias, heart block and cardiac arrest. Pain or phlebitis may occur during I.V. administration of solutions containing about 30 mmol or more potassium per litre. Nausea, vomiting, diarrhoea and abdominal cramps may occur following oral administration.

ContraindicationsView

Hypersensitivity to potassium administration e.g. hyperkalaemic periodic paralysis, congenital paramyotonia, marked renal failure (even when not yet associated with manifest hyperkalaemia), untreated Addison's disease, hyporeninaemic hypoaldosteronism, acute dehydration, hyperkalaemia and conditions involving extensive cell destruction (e.g. severe burns). In case of metabolic acidosis, the hypokalaemia should be treated not with potassium chloride.

PrecautionsView

It should be administered with caution to patients with renal or adrenocortical insufficiency, cardiac disease, acute dehydration, heat cramps, extensive tissue destruction as occurs with severe burns, or to patients receiving potassium-sparing diuretics. Excessive use of potassium-containing salt substitutes or concurrent administration with potassium supplements may lead to accumulation of potasssium especially in patients with renal insufficiency. Attention should be paid to the concurrent use of other drugs that either contain potassium or have the potential for hyperkalaemia. Treatment should be discontinued if severe nausea, vomiting or abdominal distress develops.

InteractionsView

Combined treatment with the following increase the risk of hyperkalaemia: Angiotensin-converting enzyme inhibitors, cyclosporin, NSAIDs, beta-blockers, heparin, digoxin, potassium-sparing diuretics.

Pregnancy & lactationView

As a general rule, no drugs should be taken during the first three months of pregnancy and the risks & benefits of taking drugs should be carefully considered throughout pregnancy. There are no contraindications to breastfeeding while taking potassium salts.

Pediatric usageView

Use in children: No special precautions are required.

StorageView

Store below 25°C in a dry place, away from light. Keep out of the reach of children.

Electrodex

Sodium Chloride + Dextrose

IV Infusion 0.225%+10% Allopathic Parenteral nutritional preparations

Indications

Fluid and electrolyte imbalance

Indication detailsView

This solution is indicated when there is combined water and sodium depletion. It provides Dextrose as a nutrient in a suitable medium of Sodium Chloride which is isotonic to body fluid, or it may also be employed as a source of isotonic Sodium Chloride or both. It is usually used in the maintenance and replacement of fluid, electrolyte and carbohydrate in patients who are unable to take fluid and nutrients by mouth e.g. in case of persistent vomiting, during and after surgery, shock or accidents.

Therapeutic classView

Intravenous fluid preparations, Parenteral nutritional preparations

DosageView

Dose is variable. It depends on the clinical condition, age and body surface area of the patients.

AdministrationView

Check infusion set and infusion solution prior to use.
Pull moderately to tear off the protective cover of the Eurocap.
Hold lightly the Eurocap but not the bottle body.
Open the flow regulator fully and hold the giving set on the top white area, but not the memorane venting region.
Insert the spike of the administration set to the Eurocap and fit the connector of the administration set firmly to the needle.
Gradually allow the fluid to flow down to the needletip and close.
Remove the protective cover of the needle.
Locate the venpuncture site and clean the site with an antiseptic solution, and then insert the needle.
Securely tape the puncture site.
Securely tape the wings and tubing
Start infusion while adjusting drip speed.

Side effectsView

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

ContraindicationsView

Do not take this medicine and tell your doctor if: Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

PrecautionsView

As the preparation contains Sodium Chloride, it should be administered with caution to patients with congestive heart failure, peripheral or pulmonary oedema, impaired renal function or pre-eclampsia. Serum glucose concentration should also be carefully monitored and concurrent use of insulin may be needed in case of diabetic patients. Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.

Pregnancy & lactationView

FDA pregnancy category C. It is not known whether dextrose 5% in water will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether dextrose 5% in water passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Electrosal

Hartmann's Solution

IV Infusion Allopathic Haemodialysis solutions

Indications

Vomiting

Indication detailsView

This is used to treat hypovolemia caused by surgery, hemorrhage and trauma. Excessive sweating, severe diarrhoea or vomiting, excess loss of fluid by nephritic kidneys, inadequate intake of fluid and electrolytes etc. that may lead to typical hypovolemic shock may be corrected with this solution . Severe plasma loss caused by intestinal obstruction, burns or other denuding conditions of the skin may be treated with this solution. It is mainly used as a fluid and electrolyte replenisher. It may be used as an alternative to Sodium Bicarbonate in the treatment of metabolic acidosis associated with dehydration and to alkalinized urine.

Therapeutic classView

Haemodialysis solutions

DosageView

The volume and rate of infusion will depend upon the requirements of the patients and the judgement of the physician. It usually varies with age, weight and clinical condition of the patient. The recommended flow rate is up to 100-drops/minute/70 kg body weight. In burn patients the dose of Hartmann's solution according to the Parkland formula: 4 ml/kg body weight% of Body surface area (BSA) burn (e.g. for a 30% BSA burn of a person having 60 kg body weight, 4 x 60 x 30 ml = 7200 ml of Hartmann's solution would be required in 24 hours). Half of this within 8 hr, the remainder over 16 hr.

AdministrationView

Check infusion set and infusion solution prior to use
Pull moderately to tear off the protective cover of the Eurohead
Hold lightly the Eurohead but not the bag
Open the flow regulator fully and hold the giving set on the top white area, but not the membrane venting region
Insert the spike of the administration set to the Eurohead and fit the connector of the administration set firmly to the needle
Gradually allow the fluid to flow down to the needle tip and close
Remove the protective cover of the needle
Locate the veinpuncture site and clean the site with an antiseptic solution, and then insert the needle
Securely tape the puncture site
Securely tape the wings and tubing
Start infusion while adjusting drip speed

Side effectsView

Hands, ankles and feet may become mildly swollen from fluid retention. Rarely, the lungs can also be affected, which may cause breathing difficulty. Other possible symptoms include nausea, vomiting, headache, dizziness, drowsiness, confusion, and inflammation or swelling of the veins around the site of the injection.

ContraindicationsView

Do not take this medicine and tell your doctor if: Hartmann's solution may be relatively contraindicated in patients with diabetes mellitus, as one of the isomers of lactate is gluconeogenic.

PrecautionsView

Hartmann's solution should not be administered rapidly or for prolonged periods. Since the solution contains different electrolytes, it should be infused with caution in patients where electrolyte imbalance may cause detrimental effects; e.g. in pregnancy, renal impairment, heart failure, pulmonary congestion, etc. or to patients receiving potassium sparing diuretics. In Pregnancy: Pregnancy Category C. Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process. Do not use if the solution is cloudy, contains particles, or after expiry date. Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.

Pregnancy & lactationView

Pregnancy Category C. Animal reproduction studies have not been conducted with Lactated Ringer’s Irrigation. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.

StorageView

Electrosal should be stored at controlled room temperature.

Eletam

Levetiracetam

Oral Solution 500 mg/5 ml Allopathic Adjunct anti-epileptic drugs

Indications

Seizures

Indication detailsView

Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam is indicated as adjunctive therapy-

in the treatment of partial-onset seizures with or without secondary generalization in adults, adolescents, children and infants from 1 month of age with epilepsy.
in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
in the treatment of primary generalized tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.

Therapeutic classView

Adjunct anti-epileptic drugs

DosageView

Adults and adolescents from 16 years of age: The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1500 mg twice daily.

Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more: The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment. Depending upon the clinical response and tolerability, the daily dose can be increased up to 1,500 mg twice daily. Dose changes can be made in 500 mg twice daily increases or decrease every two to four weeks.

Pediatric population: The tablet formulation is not adapted for use in infants and children under the age of 6 years. Oral solution is the preferred formulation for use in this population. In addition, the available dose strengths of the tablets are not appropriate for initial treatment in children weighing less than 25 kg, for patients unable to swallow tablets or for the administration of doses below 250 mg. In all of the above cases, oral solution should be used.

Monotherapy: The safety and efficacy of levetiracetam in children and adolescents below 16 years as monotherapy treatment have not been established.
Add-on therapy: Oral solution is the preferred formulation for use in infants and children under the age of 6 years. For children 6 years and above, oral solution should be used for doses under 250 mg, for doses not in multiples of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets. The lowest effective dose should be used. The starting dose for a child or adolescent of 25 kg should be 250 mg twice daily with a maximum dose of 750 mg twice daily. Dosing for children 50 kg or greater is the same as in adults.
Add-on therapy: For infants aged from 1 month to less than 6 months: The oral solution is the formulation to use in infants.

AdministrationView

The flm-coated tablets must be taken orally, swallowed with a sufcient quantity of liquid and may be taken with or without food. The daily dose is administered in two equally divided doses.

Side effectsView

Most common adverse reactions (incidence ≥ 5% more than placebo) include:

Adult patients: somnolence, asthenia, infection and dizziness
Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability

ContraindicationsView

Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients.

PrecautionsView

Renal impairment: The administration of levetiracetam to patients with renal impairment may require dose adjustment. In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection.

Acute kidney injury: The use of levetiracetam has been very rarely associated with acute kidney injury with a time to onset ranging from a few days to several months.

Blood cell counts: Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with levetiracetam administration, generally at the beginning of the treatment. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders.

Suicide: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam). A meta-analysis of randomized placebo-controlled trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour. The mechanism of this risk is not known. Therefore patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.

Paediatric population: The tablet formulation is not adapted for use in infants and children under the age of 6 years. Available data in children did not suggest an impact on growth and puberty. However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.

InteractionsView

Antiepileptic medicinal products: Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.

Probenecid: Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite but not of levetiracetam. Nevertheless, the concentration of this metabolite remains low.

Methotrexate: Concomitant administration of levetiracetam and methotrexate has been reported to decrease methotrexate clearance, resulting in increased/prolonged blood methotrexate concentration to potentially toxic levels. Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two drugs.

Laxatives: There have been isolated reports of decreased levetiracetam efficacy when the osmotic laxative macrogol has been concomitantly administered with oral levetiracetam. Therefore, macrogol should not be taken orally for one hour before and for one hour after taking levetiracetam.

Food and alcohol: The extent of absorption of levetiracetam was not altered by food, but the rate of absorption was slightly reduced. No data on the interaction of levetiracetam with alcohol are available.

Pregnancy & lactationView

Levetiracetam is not recommended during pregnancy and in women of childbearing potential not using contraception unless clinically necessary. Levetiracetam is excreted in human breast milk. Therefore, breastfeeding is not recommended. However, if levetiracetam treatment is needed during breastfeeding, the benefit/risk of the treatment should be weighed considering the importance of breastfeeding. No impact on fertility was detected in animal studies. No clinical data are available, the potential risk for humans is unknown.

Pediatric usageView

Elderly (65 years and older): Adjustment of the dose is recommended in elderly patients with compromised renal function.

Renal impairment: The daily dose must be individualized according to renal function.

Hepatic impairment: No dose adjustment is needed in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the creatinine clearance may underestimate renal insufficiency. Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min.

Overdose effectsView

Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with levetiracetam overdoses. After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis. There is no specifc antidote for levetiracetam. Treatment of an overdose will be symptomatic and may include haemodialysis. The dialyser extraction efficiency is 60 % for levetiracetam and 74% for the primary metabolite.

StorageView

Store at a cool temperature (not exceeding 25°C) and dry place, protected from light.

Eletam

Levetiracetam

Tablet 250 mg Allopathic Adjunct anti-epileptic drugs

Indications

Seizures

Indication detailsView

Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam is indicated as adjunctive therapy-

in the treatment of partial-onset seizures with or without secondary generalization in adults, adolescents, children and infants from 1 month of age with epilepsy.
in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
in the treatment of primary generalized tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.

Therapeutic classView

Adjunct anti-epileptic drugs

DosageView

Adults and adolescents from 16 years of age: The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1500 mg twice daily.

Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more: The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment. Depending upon the clinical response and tolerability, the daily dose can be increased up to 1,500 mg twice daily. Dose changes can be made in 500 mg twice daily increases or decrease every two to four weeks.

Pediatric population: The tablet formulation is not adapted for use in infants and children under the age of 6 years. Oral solution is the preferred formulation for use in this population. In addition, the available dose strengths of the tablets are not appropriate for initial treatment in children weighing less than 25 kg, for patients unable to swallow tablets or for the administration of doses below 250 mg. In all of the above cases, oral solution should be used.

Monotherapy: The safety and efficacy of levetiracetam in children and adolescents below 16 years as monotherapy treatment have not been established.
Add-on therapy: Oral solution is the preferred formulation for use in infants and children under the age of 6 years. For children 6 years and above, oral solution should be used for doses under 250 mg, for doses not in multiples of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets. The lowest effective dose should be used. The starting dose for a child or adolescent of 25 kg should be 250 mg twice daily with a maximum dose of 750 mg twice daily. Dosing for children 50 kg or greater is the same as in adults.
Add-on therapy: For infants aged from 1 month to less than 6 months: The oral solution is the formulation to use in infants.

AdministrationView

The flm-coated tablets must be taken orally, swallowed with a sufcient quantity of liquid and may be taken with or without food. The daily dose is administered in two equally divided doses.

Side effectsView

Most common adverse reactions (incidence ≥ 5% more than placebo) include:

Adult patients: somnolence, asthenia, infection and dizziness
Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability

ContraindicationsView

Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients.

PrecautionsView

Renal impairment: The administration of levetiracetam to patients with renal impairment may require dose adjustment. In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection.

Acute kidney injury: The use of levetiracetam has been very rarely associated with acute kidney injury with a time to onset ranging from a few days to several months.

Blood cell counts: Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with levetiracetam administration, generally at the beginning of the treatment. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders.

Suicide: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam). A meta-analysis of randomized placebo-controlled trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour. The mechanism of this risk is not known. Therefore patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.

Paediatric population: The tablet formulation is not adapted for use in infants and children under the age of 6 years. Available data in children did not suggest an impact on growth and puberty. However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.

InteractionsView

Antiepileptic medicinal products: Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.

Probenecid: Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite but not of levetiracetam. Nevertheless, the concentration of this metabolite remains low.

Methotrexate: Concomitant administration of levetiracetam and methotrexate has been reported to decrease methotrexate clearance, resulting in increased/prolonged blood methotrexate concentration to potentially toxic levels. Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two drugs.

Laxatives: There have been isolated reports of decreased levetiracetam efficacy when the osmotic laxative macrogol has been concomitantly administered with oral levetiracetam. Therefore, macrogol should not be taken orally for one hour before and for one hour after taking levetiracetam.

Food and alcohol: The extent of absorption of levetiracetam was not altered by food, but the rate of absorption was slightly reduced. No data on the interaction of levetiracetam with alcohol are available.

Pregnancy & lactationView

Levetiracetam is not recommended during pregnancy and in women of childbearing potential not using contraception unless clinically necessary. Levetiracetam is excreted in human breast milk. Therefore, breastfeeding is not recommended. However, if levetiracetam treatment is needed during breastfeeding, the benefit/risk of the treatment should be weighed considering the importance of breastfeeding. No impact on fertility was detected in animal studies. No clinical data are available, the potential risk for humans is unknown.

Pediatric usageView

Elderly (65 years and older): Adjustment of the dose is recommended in elderly patients with compromised renal function.

Renal impairment: The daily dose must be individualized according to renal function.

Hepatic impairment: No dose adjustment is needed in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the creatinine clearance may underestimate renal insufficiency. Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min.

Overdose effectsView

Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with levetiracetam overdoses. After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis. There is no specifc antidote for levetiracetam. Treatment of an overdose will be symptomatic and may include haemodialysis. The dialyser extraction efficiency is 60 % for levetiracetam and 74% for the primary metabolite.

StorageView

Store at a cool temperature (not exceeding 25°C) and dry place, protected from light.