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Iventi
Moxifloxacin Hydrochloride (Injection)
Iventi
Moxifloxacin Hydrochloride (Injection)
Indications
Skin and skin sructure infections
Indication detailsView
Moxifloxacin infusion is indicated for treating following infections in adults >18 years of age caused by designated, susceptible bacteria.
- Acute Bacterial Sinusitis
- Acute Bacterial Exacerbation of Chronic Bronchitis
- Community Acquired Pneumonia
- Skin and Skin Structure Infections: Uncomplicated and Complicated
- Complicated Intra-Abdominal Infections.
Therapeutic classView
4-Quinolone preparations
DosageView
The dose of Moxifloxacin is 400 mg once daily. The duration of therapy depends on the type of infection as described in following:
- Acute Bacterial Sinusitis: 400 mg once daily for 10 days.
- Acute Bacterial Exacerbation of Chronic Bronchitis: 400 mg once daily for 5 days.
- Community Acquired Pneumonia: 400 mg once daily for 7-14 days.
- Uncomplicated Skin and Skin Structure Infections: 400 mg once daily for 7 days.
- Complicated Skin and Skin Structure Infections: 400 mg once daily for 7-21 days.
- Complicated Intra-Abdominal Infections: 400 mg once daily for 5-14 days.
AdministrationView
Moxifloxacin injection should be administered by intravenous infusion over a period of 60 minutes. Avoid bolus or rapid infusion.
- Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
- Do not use if the solution is cloudy or a precipitate is present.
- Do not use flexible bags in series connections.
- Close flow control clamp of administration set.
- Remove cover from port at bottom of bag.
- Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
- Suspend bag from hanger.
- Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Moxifloxacin 400 mg intravenous infusion.
- Open flow control clamp to expel air from set. Close clamp.
- Regulate the rate of administration with flow control clamp.
Side effectsView
Treatment with Moxifloxacin (oral, IV or sequential therapy) may cause some side effects. Common (>1%) side effects include headache, nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, dizziness, pyrexia and insomnia etc. Less common (0.1 to <1%) side effects include neutropenia, palpitations, tachycardia, bradycardia, vertigo, tinnitus, dry mouth, gastritis, edema, fatigue, malaise, hyperglycemia, anorexia, hyperlipidemia, hypoglycemia, dehydration, back pain and arthralgia etc.
ContraindicationsView
Moxifloxacin is contraindicated in persons with known hypersensitivity to Moxifloxacin or other quinolone antibacterials .
PrecautionsView
Fluoroquinolones, including Moxifloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Moxifloxacin, and may range in severity from mild diarrhea to fatal colitis.
InteractionsView
There are no data concerning an interaction of intravenous fluoroquinolones with oral antacids, sucralfate, multivitamins, didanosine, or metal cations. However, no fluoroquinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Quinolones, including Moxifloxacin, have been reported to enhance the anticoagulant effects of warfarin or its derivatives in the patient population. Although not observed with Moxifloxacin in predinical and clinical trials, the concomitant administration of a nonsteroidal anti-inflammatory drug with a quinolone may increase the risks of CNS stimulation and convulsions. There is limited information available on the potential for a pharmacodynamic interaction in humans between Moxifloxacin and other drugs that prolong the QTc interval of the electrocardiogram. Sotalol, a Class III antiarrhythmic, has been shown to further increase the QTc interval when combined with high doses of intravenous (IV) Moxifloxacin in dogs. Therefore, Moxifloxacin should be avoided with Class IA and Class III antiarrhythmics.
Pregnancy & lactationView
Pregnancy Category C. Because no adequate or well controlled studies have been conducted in pregnant women, Moxifloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Moxifloxacin is excreted in the breast milk of rats. Moxifloxacin may also be excreted in human milk. Because of the potential for serious adverse reactions in infants who are nursing from mothers taking Moxifloxacin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric patients: Safety and effectiveness in pediatric patients and adolescents less than 18 years of age have not been established.
Geriatric patients: These patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Moxifloxacin. This risk is further increased in patients receiving concomitant corticosteroid therapy.
Geriatric patients: These patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Moxifloxacin. This risk is further increased in patients receiving concomitant corticosteroid therapy.
StorageView
Store below 25°C and protect from light. Avoid extreme heat and freezing. Keep out of reach of children.
Iventi
Moxifloxacin Hydrochloride (Ophthalmic)
Iventi
Moxifloxacin Hydrochloride (Ophthalmic)
Indications
Ocular infections
Indication detailsView
The ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
- Aerobic Gram-positive microorganisms: Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumoniae, Streptococcus viridans group.
- Aerobic Gram-negative microorganisms: Acinetobacterlwoffii, Haemophilusinfluenzae, Haemophilus parainfluenzae.
- Other microorganisms: Chlamydia trachomatis.
Therapeutic classView
Ophthalmic antibacterial drugs
PharmacologyView
The antimicrobial action of Moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.
DosageView
Eye Drops: One drop in the affected eye 3 times per day for 7 days.
Eye Ointment: It should be applied thinly and evenly to the affected eye three times a day for the first two days and for the next five days apply two times a day or as advised by the registered physician.
Eye Ointment: It should be applied thinly and evenly to the affected eye three times a day for the first two days and for the next five days apply two times a day or as advised by the registered physician.
Side effectsView
The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1-6% of patients. Nonocular adverse events reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.
ContraindicationsView
Moxifloxacin Hydrochloride ophthalmic solution is contraindicated in patients with a history of hypersensitivity to Moxifloxacin, to other quinolones, or to any of the components in this medication.
PrecautionsView
As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
InteractionsView
Drug-drug interaction studies have not been conducted with Moxifloxacin Hydrochloride ophthalmic solution. In vitro studies indicate that Moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2 indicating that Moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes.
Pregnancy & lactationView
Since there are no adequate and well-controlled studies in pregnant women, Moxifloxacin Hydrochloride ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Moxifloxacin hydrochloride ophthalmic solution is administered to a nursing mother.
StorageView
Store bellow 25°C. Do not freeze. Store in cool and dry place, protected from light. Keep out of the reach of children. Do not touch dropper tip to any surface as this may contaminate this preparation. Do not use after one month of first opening.
Iventi
Moxifloxacin Hydrochloride (Tablet)
Iventi
Moxifloxacin Hydrochloride (Tablet)
Indications
Acute bacterial sinusitis
Indication detailsView
Moxifloxacin is indicated for the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community acquired pneumonia, uncomplicated & complicated skin and skin structure infections, complicated intra-abdominal infections and pelvic inflammatory disease.
Therapeutic classView
4-Quinolone preparations
PharmacologyView
Moxifloxacin is a 4th generation synthetic broad spectrum, fluoroquinolone class of antibacterial drug. It has activity against a wide range of gram-positive, gram-negative, anaerobic and atypical bacteria including Mycoplasma pneumoniae. It acts by inhibiting topoisomerase II (DNA gyrase) and topoisomerase IV which are necessary for bacterial DNA replication, transcription & repair.
DosageView
Acute bacterial sinusitis: 400 mg once daily 7-10 days.
Acute bacterial exacerbation of chronic bronchitis: 400 mg once daily 5-10 days.
Community-acquired pneumonia: 400 mg once daily 7-14 days.
Uncomplicated skin and skin structure infections: 400 mg once daily 7 days.
Complicated skin and skin structure infections: 400 mg once daily 7-21 days.
Complicated intra-abdominal infections: 400 mg once daily 5-14 days.
Pelvic inflammatory disease: 400 mg once daily 14 days.
Acute bacterial exacerbation of chronic bronchitis: 400 mg once daily 5-10 days.
Community-acquired pneumonia: 400 mg once daily 7-14 days.
Uncomplicated skin and skin structure infections: 400 mg once daily 7 days.
Complicated skin and skin structure infections: 400 mg once daily 7-21 days.
Complicated intra-abdominal infections: 400 mg once daily 5-14 days.
Pelvic inflammatory disease: 400 mg once daily 14 days.
Side effectsView
Common side effects of Moxifloxacin include nausea, vomiting, diarrhea, headache and dizziness.
ContraindicationsView
It is contraindicated in patients with a history of hypersensitivity to Moxifloxacin or other quinolones.
PrecautionsView
Moxifloxacin may cause an increased risk of tendinitis and tendon rupture. It should be discontinued if pain or inflammation in a tendon occurs. It should not be used in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients with receiving Class IA or Class III antiarrhythmic agents
InteractionsView
Moxifloxacin absorption is decreased when administered with antacids, sucralfate, multivitamins, and multivalent cations (e.g. iron or zinc). Moxifloxacin may enhance the risk of convulsions with NSAIDs and bleeding with warfarin. So concomitant use of Moxifloxacin with them should be avoided.
Pregnancy & lactationView
US FDA pregnancy category C. Moxifloxacin is not recommended during pregnancy & lactation.
Pediatric usageView
Renal or hepatic impaired patients: No dose adjustment is necessary for patients with renal or hepatic impairment.
Pediatric patients: Safety and effectiveness of Moxifloxacin in pediatric patients and adolescent less than 18 years of age have not been established.
Pediatric patients: Safety and effectiveness of Moxifloxacin in pediatric patients and adolescent less than 18 years of age have not been established.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Iventi-D
Moxifloxacin Hydrochloride + Dexamethasone
Iventi-D
Moxifloxacin Hydrochloride + Dexamethasone
Indications
Steroid-responsive inflammatory ocular conditions
Indication detailsView
Moxifloxacin & Dexamethasone eye drop is indicated in the treatment of eye infections caused by susceptible microorganisms and in the prevention of inflammation and bacterial infection that may occur after eye surgery.
Therapeutic classView
Ophthalmic Steroid preparations
PharmacologyView
This Eye Drops is a combination of a fourth generation fluoroquinolone Moxifloxacin and a potent corticosteroid Dexmethasone. Moxifloxacin controls infection by inhibitting the DNA gyrase & Topoisomerase IV. Dexamethasone effectively controls the inflammation by inhibiting the release inflammatory mediators.
DosageView
In the prevention of infection and post-surgical ocular inflammation: Instill 1 drop, 4 times a day, in the eye to be operated, from 1 day before surgery until 15 days after surgery.
In patients undergoing cataract surgery: The day of surgery instill the medication immediately after eye surgery.
In patients undergoing LASIK refractive surgery: On the day of surgery instill the medication at least 15 minutes after ocular surgery.
In eye infections caused by susceptible microorganisms: Instill 1 drop, 4 times a day, for up to 7 days.
In patients undergoing cataract surgery: The day of surgery instill the medication immediately after eye surgery.
In patients undergoing LASIK refractive surgery: On the day of surgery instill the medication at least 15 minutes after ocular surgery.
In eye infections caused by susceptible microorganisms: Instill 1 drop, 4 times a day, for up to 7 days.
Side effectsView
Moxifloxacin: Conjunctivitis decreased visual acuity, dry eye, keratitis, Ocular discomfort, hyperemia, pain, Subconjunctival hemorrhage and tearing.
Dexamethasone: Visual acuity & field defects, cataract formation, secondary ocular infection following suppression of host response & perforation of the globe.
Dexamethasone: Visual acuity & field defects, cataract formation, secondary ocular infection following suppression of host response & perforation of the globe.
ContraindicationsView
Hypersensitivity to quinolones. Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella & other viral diseases of cornea & conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Glaucoma & diseases causing thinning of cornea or sclera.
PrecautionsView
For ophthalmic use only. The solution should not be injected under the conjunctiva, nor introduced directly into the anterior chamber of the eye. Prolonged use of steroids may result in ocular hypertension
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Moxifloxacin & Dexamethasone combination eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution is advised when Moxifloxacin & Dexamethasone combination eye drops is given to nursing women.
Pediatric usageView
Use in the elderly: No change in dosage is required when the product is administered in elderly patients.
Use in Children: The efficacy and safety of Moxifloxacin & Dexamethasone combination eye drops in pediatric patients have not been established.
Use in Children: The efficacy and safety of Moxifloxacin & Dexamethasone combination eye drops in pediatric patients have not been established.
Overdose effectsView
No information is available on overdosage with this product in humans.
StorageView
Store in a cool place, below 30°C, protected from light. Once the container is opened the contents must be used within 28 days and may be stored at room temperature up to 30°C. Discard after the 28 days. Keep out of reach of children.
Ivera
Ivermectin (Tablet)
Ivera
Ivermectin (Tablet)
Indication detailsView
Strongyloidiasis of the intestinal tract: Ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin.
Onchocerciasis: Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).
Onchocerciasis: Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).
Therapeutic classView
Anthelmintic
PharmacologyView
Ivermectin selectively binds and with high affinity to glutamate-gated chloride ion channels, which occur in invertebrate nerve and muscle cells leading to an increase in the permeability of cell membranes to chloride ions with hyperpolarization of the nerve or muscle cell and, ultimately, death of the parasite.
DosageView
For Treatment (If COVIO Positive): 2 Tablets of Ivermectin 6 mg once daily for 5 days. (2+0+0 for 5 days).
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.
Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.
Dosage Guidelines for Ivermectin for Strongyloidiasis:
Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.
Dosage Guidelines for Ivermectin for Onchocerciasis:
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.
- Body Weight 15-24 kg: 1 Tablet of Ivermectin 3 mg
- Body Weight 25-35 kg: 1 Tablet of Ivermectin 6 mg
- Body Weight 36-50 kg: 1 Tablet of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
- Body Weight 51-65 kg: 2 Tablets of Ivermectin 6 mg
- Body Weight 66-79 kg: 2 Tablets of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
- Body Weight >80 kg: 3 Tablets of Ivermectin 6 mg
Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.
Dosage Guidelines for Ivermectin for Strongyloidiasis:
- Body Weight (kg) 15-24: Dose 3 mg/kg
- Body Weight (kg) 25-35: Dose 6 mg/kg
- Body Weight (kg) 36-50: Dose 9 mg/kg
- Body Weight (kg) 51-65: Dose 12 mg/kg
- Body Weight (kg) 66-79: Dose 15 mg/kg
- Body Weight (kg) >80: Dose 200 mcg/kg
Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.
Dosage Guidelines for Ivermectin for Onchocerciasis:
- Body Weight (kg) 15-25: Dose 3 mg/kg
- Body Weight (kg) 26-44: Dose 6 mg/kg
- Body Weight (kg) 45-64: Dose 9 mg/kg
- Body Weight (kg) 65-84: Dose 12 mg/kg
- Body Weight (kg) >85: Dose 150 mcg/kg
Side effectsView
Strongyloidiasis: In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of Ivermectin, the following adverse reactions were reported as possibly, probably, or definitely related to Ivermectin.
- Body as a whole: asthenia/fatigue (0.9%), abdominal pain (0.9%)
- Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%) Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%)
- Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%).
ContraindicationsView
It is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with Ivermectin for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself. The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases. After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more likely than others to experience severe adverse reactions, especially edema and aggravation of onchodermatitis. Rarely, patients with onchocerciasis who are also heavily infected with Loa loa may develop a serious or even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide. In these patients, the following adverse experiences have also been reported: back pain, conjunctival hemorrhage, dyspnea, urinary and/or fecal incontinence, difficulty in standing/walking, mental status changes, confusion, lethargy, stupor, or coma.
InteractionsView
Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was co-administered with warfarin.
Pregnancy & lactationView
Pregnancy Category C. Ivermectin does not appear to be selectively fetotoxic to the developing fetus. There are, however, no adequate and well-controlled studies in pregnant women. Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.
Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn
Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn
Pediatric usageView
Pediatric Use: Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.
Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
StorageView
Keep in a dry place, below 30°C. Protect from light. Keep out of the reach of children.
Ivera
Ivermectin (Tablet)
Ivera
Ivermectin (Tablet)
Indication detailsView
Strongyloidiasis of the intestinal tract: Ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin.
Onchocerciasis: Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).
Onchocerciasis: Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).
Therapeutic classView
Anthelmintic
PharmacologyView
Ivermectin selectively binds and with high affinity to glutamate-gated chloride ion channels, which occur in invertebrate nerve and muscle cells leading to an increase in the permeability of cell membranes to chloride ions with hyperpolarization of the nerve or muscle cell and, ultimately, death of the parasite.
DosageView
For Treatment (If COVIO Positive): 2 Tablets of Ivermectin 6 mg once daily for 5 days. (2+0+0 for 5 days).
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.
Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.
Dosage Guidelines for Ivermectin for Strongyloidiasis:
Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.
Dosage Guidelines for Ivermectin for Onchocerciasis:
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.
- Body Weight 15-24 kg: 1 Tablet of Ivermectin 3 mg
- Body Weight 25-35 kg: 1 Tablet of Ivermectin 6 mg
- Body Weight 36-50 kg: 1 Tablet of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
- Body Weight 51-65 kg: 2 Tablets of Ivermectin 6 mg
- Body Weight 66-79 kg: 2 Tablets of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
- Body Weight >80 kg: 3 Tablets of Ivermectin 6 mg
Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.
Dosage Guidelines for Ivermectin for Strongyloidiasis:
- Body Weight (kg) 15-24: Dose 3 mg/kg
- Body Weight (kg) 25-35: Dose 6 mg/kg
- Body Weight (kg) 36-50: Dose 9 mg/kg
- Body Weight (kg) 51-65: Dose 12 mg/kg
- Body Weight (kg) 66-79: Dose 15 mg/kg
- Body Weight (kg) >80: Dose 200 mcg/kg
Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.
Dosage Guidelines for Ivermectin for Onchocerciasis:
- Body Weight (kg) 15-25: Dose 3 mg/kg
- Body Weight (kg) 26-44: Dose 6 mg/kg
- Body Weight (kg) 45-64: Dose 9 mg/kg
- Body Weight (kg) 65-84: Dose 12 mg/kg
- Body Weight (kg) >85: Dose 150 mcg/kg
Side effectsView
Strongyloidiasis: In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of Ivermectin, the following adverse reactions were reported as possibly, probably, or definitely related to Ivermectin.
- Body as a whole: asthenia/fatigue (0.9%), abdominal pain (0.9%)
- Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%) Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%)
- Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%).
ContraindicationsView
It is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with Ivermectin for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself. The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases. After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more likely than others to experience severe adverse reactions, especially edema and aggravation of onchodermatitis. Rarely, patients with onchocerciasis who are also heavily infected with Loa loa may develop a serious or even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide. In these patients, the following adverse experiences have also been reported: back pain, conjunctival hemorrhage, dyspnea, urinary and/or fecal incontinence, difficulty in standing/walking, mental status changes, confusion, lethargy, stupor, or coma.
InteractionsView
Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was co-administered with warfarin.
Pregnancy & lactationView
Pregnancy Category C. Ivermectin does not appear to be selectively fetotoxic to the developing fetus. There are, however, no adequate and well-controlled studies in pregnant women. Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.
Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn
Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn
Pediatric usageView
Pediatric Use: Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.
Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
StorageView
Keep in a dry place, below 30°C. Protect from light. Keep out of the reach of children.
Ivertin
Ivermectin (Tablet)
Ivertin
Ivermectin (Tablet)
Indication detailsView
Strongyloidiasis of the intestinal tract: Ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin.
Onchocerciasis: Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).
Onchocerciasis: Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).
Therapeutic classView
Anthelmintic
PharmacologyView
Ivermectin selectively binds and with high affinity to glutamate-gated chloride ion channels, which occur in invertebrate nerve and muscle cells leading to an increase in the permeability of cell membranes to chloride ions with hyperpolarization of the nerve or muscle cell and, ultimately, death of the parasite.
DosageView
For Treatment (If COVIO Positive): 2 Tablets of Ivermectin 6 mg once daily for 5 days. (2+0+0 for 5 days).
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.
Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.
Dosage Guidelines for Ivermectin for Strongyloidiasis:
Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.
Dosage Guidelines for Ivermectin for Onchocerciasis:
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.
- Body Weight 15-24 kg: 1 Tablet of Ivermectin 3 mg
- Body Weight 25-35 kg: 1 Tablet of Ivermectin 6 mg
- Body Weight 36-50 kg: 1 Tablet of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
- Body Weight 51-65 kg: 2 Tablets of Ivermectin 6 mg
- Body Weight 66-79 kg: 2 Tablets of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
- Body Weight >80 kg: 3 Tablets of Ivermectin 6 mg
Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.
Dosage Guidelines for Ivermectin for Strongyloidiasis:
- Body Weight (kg) 15-24: Dose 3 mg/kg
- Body Weight (kg) 25-35: Dose 6 mg/kg
- Body Weight (kg) 36-50: Dose 9 mg/kg
- Body Weight (kg) 51-65: Dose 12 mg/kg
- Body Weight (kg) 66-79: Dose 15 mg/kg
- Body Weight (kg) >80: Dose 200 mcg/kg
Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.
Dosage Guidelines for Ivermectin for Onchocerciasis:
- Body Weight (kg) 15-25: Dose 3 mg/kg
- Body Weight (kg) 26-44: Dose 6 mg/kg
- Body Weight (kg) 45-64: Dose 9 mg/kg
- Body Weight (kg) 65-84: Dose 12 mg/kg
- Body Weight (kg) >85: Dose 150 mcg/kg
Side effectsView
Strongyloidiasis: In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of Ivermectin, the following adverse reactions were reported as possibly, probably, or definitely related to Ivermectin.
- Body as a whole: asthenia/fatigue (0.9%), abdominal pain (0.9%)
- Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%) Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%)
- Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%).
ContraindicationsView
It is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with Ivermectin for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself. The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases. After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more likely than others to experience severe adverse reactions, especially edema and aggravation of onchodermatitis. Rarely, patients with onchocerciasis who are also heavily infected with Loa loa may develop a serious or even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide. In these patients, the following adverse experiences have also been reported: back pain, conjunctival hemorrhage, dyspnea, urinary and/or fecal incontinence, difficulty in standing/walking, mental status changes, confusion, lethargy, stupor, or coma.
InteractionsView
Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was co-administered with warfarin.
Pregnancy & lactationView
Pregnancy Category C. Ivermectin does not appear to be selectively fetotoxic to the developing fetus. There are, however, no adequate and well-controlled studies in pregnant women. Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.
Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn
Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn
Pediatric usageView
Pediatric Use: Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.
Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
StorageView
Keep in a dry place, below 30°C. Protect from light. Keep out of the reach of children.
Iverum
Ivermectin (Tablet)
Iverum
Ivermectin (Tablet)
Indication detailsView
Strongyloidiasis of the intestinal tract: Ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin.
Onchocerciasis: Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).
Onchocerciasis: Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).
Therapeutic classView
Anthelmintic
PharmacologyView
Ivermectin selectively binds and with high affinity to glutamate-gated chloride ion channels, which occur in invertebrate nerve and muscle cells leading to an increase in the permeability of cell membranes to chloride ions with hyperpolarization of the nerve or muscle cell and, ultimately, death of the parasite.
DosageView
For Treatment (If COVIO Positive): 2 Tablets of Ivermectin 6 mg once daily for 5 days. (2+0+0 for 5 days).
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.
Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.
Dosage Guidelines for Ivermectin for Strongyloidiasis:
Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.
Dosage Guidelines for Ivermectin for Onchocerciasis:
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.
- Body Weight 15-24 kg: 1 Tablet of Ivermectin 3 mg
- Body Weight 25-35 kg: 1 Tablet of Ivermectin 6 mg
- Body Weight 36-50 kg: 1 Tablet of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
- Body Weight 51-65 kg: 2 Tablets of Ivermectin 6 mg
- Body Weight 66-79 kg: 2 Tablets of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
- Body Weight >80 kg: 3 Tablets of Ivermectin 6 mg
Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.
Dosage Guidelines for Ivermectin for Strongyloidiasis:
- Body Weight (kg) 15-24: Dose 3 mg/kg
- Body Weight (kg) 25-35: Dose 6 mg/kg
- Body Weight (kg) 36-50: Dose 9 mg/kg
- Body Weight (kg) 51-65: Dose 12 mg/kg
- Body Weight (kg) 66-79: Dose 15 mg/kg
- Body Weight (kg) >80: Dose 200 mcg/kg
Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.
Dosage Guidelines for Ivermectin for Onchocerciasis:
- Body Weight (kg) 15-25: Dose 3 mg/kg
- Body Weight (kg) 26-44: Dose 6 mg/kg
- Body Weight (kg) 45-64: Dose 9 mg/kg
- Body Weight (kg) 65-84: Dose 12 mg/kg
- Body Weight (kg) >85: Dose 150 mcg/kg
Side effectsView
Strongyloidiasis: In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of Ivermectin, the following adverse reactions were reported as possibly, probably, or definitely related to Ivermectin.
- Body as a whole: asthenia/fatigue (0.9%), abdominal pain (0.9%)
- Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%) Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%)
- Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%).
ContraindicationsView
It is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with Ivermectin for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself. The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension. Antihistamines and/or aspirin have been used for most mild to moderate cases. After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more likely than others to experience severe adverse reactions, especially edema and aggravation of onchodermatitis. Rarely, patients with onchocerciasis who are also heavily infected with Loa loa may develop a serious or even fatal encephalopathy either spontaneously or following treatment with an effective microfilaricide. In these patients, the following adverse experiences have also been reported: back pain, conjunctival hemorrhage, dyspnea, urinary and/or fecal incontinence, difficulty in standing/walking, mental status changes, confusion, lethargy, stupor, or coma.
InteractionsView
Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was co-administered with warfarin.
Pregnancy & lactationView
Pregnancy Category C. Ivermectin does not appear to be selectively fetotoxic to the developing fetus. There are, however, no adequate and well-controlled studies in pregnant women. Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.
Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn
Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn
Pediatric usageView
Pediatric Use: Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.
Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
StorageView
Keep in a dry place, below 30°C. Protect from light. Keep out of the reach of children.
Ivolol
Nebivolol Hydrochloride
Ivolol
Nebivolol Hydrochloride
Indications
Hypertension
Indication detailsView
Nebivolol is indicated in-
- Hypertension
- Treatment of essential hypertension
- Chronic heart failure (CHF)
- Treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients.
Therapeutic classView
Beta-adrenoceptor blocking drugs, Beta-blockers
PharmacologyView
Nebivolol is a β adrenergic receptor blocking agent. Nebivolol inhibits both β1 and β1 adrenergic receptors. Nebivolol lacks intrinsic sympathomimetic and membrane stabilizing activity at therapeutically relevant concentrations. At clinically relevant doses, Nebivolol does not demonstrate β1-adrenergic receptor blockade activity. Various metabolites, including glucuronides, contribute to beta-blocking activity.
Mode of Action of Nebivolol involved include:
Absorption and Distribution: Absorption of Nebivolol is similar to an oral solution. Mean peak plasma nebivolol concentrations occur approximately 1.5 to 4 hours post-dosing in EMs and PMs. Food does not alter the pharmacokinetics of nebivolol. Nebivolol may be administered without regard to meals. The in vitro human plasma protein binding of nebivolol is approximately 98%, mostly to albumin, and is independent of nebivolol concentrations.
Metabolism and Excretion: Nebivolol is predominantly metabolized via direct glucuronidation of parent and to a lesser extent via N-dealkylation and oxidation via cytochrome P450 2D6. After a single oral administration of 14C-nebivolol, 38% of the dose was recovered in urine and 44% in feces for EMs and 67% in urine and 13% in feces for PMs.
Digoxin: Concomitant administration of Nebivolol (10 mg once daily) and digoxin (0.25 mg once daily) for 10 days in 14 healthy adult individuals resulted in no significant changes in the pharmacokinetics of digoxin or nebivolol.
Warfarin: Administration of Nebivolol (10 mg once daily for 10 days) led to no significant changes in the pharmacokinetics of nebivolol or R- or S-warfarin following a single 10 mg dose of warfarin. Similarly, nebivolol has no significant effects on the anticoagulant activity of warfarin, as assessed by Prothrombin time and INR profiles from 0 to 144 hours after a single 10 mg warfarin dose in 12 healthy adult volunteers. The starting dose should be reduced in patients with moderate hepatic impairment. No formal studies have been performed in patients with severe hepatic impairment and nebivolol should be contraindicated for these patients.
Mode of Action of Nebivolol involved include:
- decreased heart rate
- decreased myocardia contractility
- diminution of tonic sympathetic outflow to the periphery from cerebral vasomotor centers
- suppression of renin activity and
- vasodilation and decreased peripheral vascular resistance
Absorption and Distribution: Absorption of Nebivolol is similar to an oral solution. Mean peak plasma nebivolol concentrations occur approximately 1.5 to 4 hours post-dosing in EMs and PMs. Food does not alter the pharmacokinetics of nebivolol. Nebivolol may be administered without regard to meals. The in vitro human plasma protein binding of nebivolol is approximately 98%, mostly to albumin, and is independent of nebivolol concentrations.
Metabolism and Excretion: Nebivolol is predominantly metabolized via direct glucuronidation of parent and to a lesser extent via N-dealkylation and oxidation via cytochrome P450 2D6. After a single oral administration of 14C-nebivolol, 38% of the dose was recovered in urine and 44% in feces for EMs and 67% in urine and 13% in feces for PMs.
Digoxin: Concomitant administration of Nebivolol (10 mg once daily) and digoxin (0.25 mg once daily) for 10 days in 14 healthy adult individuals resulted in no significant changes in the pharmacokinetics of digoxin or nebivolol.
Warfarin: Administration of Nebivolol (10 mg once daily for 10 days) led to no significant changes in the pharmacokinetics of nebivolol or R- or S-warfarin following a single 10 mg dose of warfarin. Similarly, nebivolol has no significant effects on the anticoagulant activity of warfarin, as assessed by Prothrombin time and INR profiles from 0 to 144 hours after a single 10 mg warfarin dose in 12 healthy adult volunteers. The starting dose should be reduced in patients with moderate hepatic impairment. No formal studies have been performed in patients with severe hepatic impairment and nebivolol should be contraindicated for these patients.
DosageView
The dose of Nebivolol should be individualized to the needs of the patient. For most patients, the recommended starting dose is 5 mg once daily, with or without food, as monotherapy or in combination with other agents. For patients requiring further reduction in blood pressure, the dose can be increased at 2-week intervals up to 40 mg. A more frequent dosing regimen is unlikely to be beneficial.
Side effectsView
Headache, nausea and bradycardia.
ContraindicationsView
Nebivolol is contraindicated in patients with severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), or severe hepatic impairment (Child-Pugh >B), and in patients who are hypersensitive to any component of this product.
PrecautionsView
Abrupt Cessation of Therapy: Patients with coronary artery disease treated with Nebivolol should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with β-blockers. Myocardial infarction and ventricular arrhythmias may occur with or without preceding exacerbation of the angina pectoris. Even patients without overt coronary artery disease should be cautioned against interruption or abrupt discontinuation of therapy. As with other β-blockers, when discontinuation of Nebivolol is planned, patients should be carefully observed and advised to minimize physical activity. Nebivolol should be tapered over 1 to 2 weeks when possible. If the angina worsens or acute coronary insufficiency develops, it is recommended that Nebivolol be promptly reinstituted, at least temporarily.
Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure, and (β-blockade may result in further depression of myocardial contractility and precipitate more severe failure. In patients who have compensated congestive heart failure, Nebivolol should be administered cautiously. If heart failure worsens, discontinuation of Nebivolol should be considered.
Angina and Acute Myocardial Infarction: Nebivolol was not studied in patients with angina pectoris or who had a recent Ml.
Bronchospastic Diseases: In general, patients with bronchospastic diseases should not receive (3-blockers.
Anesthesia and Major Surgery: If Nebivolol is to be continued perioperatively, patients should be closely monitored when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used. If β-blocking therapy is withdrawn prior to major surgery, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. The β-blocking effects of Nebivolol can be reversed by β-agonists, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Additionally, difficulty in restarting and maintaining the heartbeat has been reported with (β-blockers).
Diabetes and Hypoglycemia: β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective β-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. It is not known whether nebivolol has these effects. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be advised about these possibilities and nebivolol should be used with caution.
Thyrotoxicosis: β-blockers may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of β-blockers may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate a thyroid storm.
Peripheral Vascular Disease: β-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in these patients.
Non-dihydropyridine Calcium Channel Blockers: Because of significant negative inotropic and chronotropic effects in patients treated with β-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be used in patients treated concomitantly with these agents and ECG and blood pressure should be monitored.
Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure, and (β-blockade may result in further depression of myocardial contractility and precipitate more severe failure. In patients who have compensated congestive heart failure, Nebivolol should be administered cautiously. If heart failure worsens, discontinuation of Nebivolol should be considered.
Angina and Acute Myocardial Infarction: Nebivolol was not studied in patients with angina pectoris or who had a recent Ml.
Bronchospastic Diseases: In general, patients with bronchospastic diseases should not receive (3-blockers.
Anesthesia and Major Surgery: If Nebivolol is to be continued perioperatively, patients should be closely monitored when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used. If β-blocking therapy is withdrawn prior to major surgery, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. The β-blocking effects of Nebivolol can be reversed by β-agonists, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Additionally, difficulty in restarting and maintaining the heartbeat has been reported with (β-blockers).
Diabetes and Hypoglycemia: β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective β-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. It is not known whether nebivolol has these effects. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be advised about these possibilities and nebivolol should be used with caution.
Thyrotoxicosis: β-blockers may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of β-blockers may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate a thyroid storm.
Peripheral Vascular Disease: β-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in these patients.
Non-dihydropyridine Calcium Channel Blockers: Because of significant negative inotropic and chronotropic effects in patients treated with β-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be used in patients treated concomitantly with these agents and ECG and blood pressure should be monitored.
InteractionsView
Nebivolol should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently. Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Nebivolol should not be combined with other β-blockers. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored, because the added β-blocking action of Nebivolol may produce excessive reduction of sympathetic activity. In patients who are receiving Nebivolol and clonidine, Nebivolol should be discontinued for several days before the gradual tapering of clonidine.
CYP2D6 Inhibitors: Use caution when Nebivolol is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)
Nebivolol should not be combined with other β-blockers. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored, because the added β-blocking action of Nebivolol may produce excessive reduction of sympathetic activity. In patients who are receiving Nebivolol and clonidine, Nebivolol should be discontinued for several days before the gradual tapering of clonidine.
CYP2D6 Inhibitors: Use caution when Nebivolol is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)
Pediatric usageView
Impaired Renal Function: Nebivolol should be used with caution in patients with severe renal impairment because of decreased renal clearance. Nebivolol has not been studied in patients receiving dialysis.
Impaired Hepatic Function: Nebivolol should be used with caution in patients with moderate hepatic impairment because of decreased metabolism. Since Nebivolol has not been studied in patients with severe hepatic impairment, Nebivolol is contraindicated in this population.
Risk of Anaphylactic Reactions: While taking β-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenges either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
Impaired Hepatic Function: Nebivolol should be used with caution in patients with moderate hepatic impairment because of decreased metabolism. Since Nebivolol has not been studied in patients with severe hepatic impairment, Nebivolol is contraindicated in this population.
Risk of Anaphylactic Reactions: While taking β-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenges either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Ivolol
Nebivolol Hydrochloride
Ivolol
Nebivolol Hydrochloride
Indications
Hypertension
Indication detailsView
Nebivolol is indicated in-
- Hypertension
- Treatment of essential hypertension
- Chronic heart failure (CHF)
- Treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients.
Therapeutic classView
Beta-adrenoceptor blocking drugs, Beta-blockers
PharmacologyView
Nebivolol is a β adrenergic receptor blocking agent. Nebivolol inhibits both β1 and β1 adrenergic receptors. Nebivolol lacks intrinsic sympathomimetic and membrane stabilizing activity at therapeutically relevant concentrations. At clinically relevant doses, Nebivolol does not demonstrate β1-adrenergic receptor blockade activity. Various metabolites, including glucuronides, contribute to beta-blocking activity.
Mode of Action of Nebivolol involved include:
Absorption and Distribution: Absorption of Nebivolol is similar to an oral solution. Mean peak plasma nebivolol concentrations occur approximately 1.5 to 4 hours post-dosing in EMs and PMs. Food does not alter the pharmacokinetics of nebivolol. Nebivolol may be administered without regard to meals. The in vitro human plasma protein binding of nebivolol is approximately 98%, mostly to albumin, and is independent of nebivolol concentrations.
Metabolism and Excretion: Nebivolol is predominantly metabolized via direct glucuronidation of parent and to a lesser extent via N-dealkylation and oxidation via cytochrome P450 2D6. After a single oral administration of 14C-nebivolol, 38% of the dose was recovered in urine and 44% in feces for EMs and 67% in urine and 13% in feces for PMs.
Digoxin: Concomitant administration of Nebivolol (10 mg once daily) and digoxin (0.25 mg once daily) for 10 days in 14 healthy adult individuals resulted in no significant changes in the pharmacokinetics of digoxin or nebivolol.
Warfarin: Administration of Nebivolol (10 mg once daily for 10 days) led to no significant changes in the pharmacokinetics of nebivolol or R- or S-warfarin following a single 10 mg dose of warfarin. Similarly, nebivolol has no significant effects on the anticoagulant activity of warfarin, as assessed by Prothrombin time and INR profiles from 0 to 144 hours after a single 10 mg warfarin dose in 12 healthy adult volunteers. The starting dose should be reduced in patients with moderate hepatic impairment. No formal studies have been performed in patients with severe hepatic impairment and nebivolol should be contraindicated for these patients.
Mode of Action of Nebivolol involved include:
- decreased heart rate
- decreased myocardia contractility
- diminution of tonic sympathetic outflow to the periphery from cerebral vasomotor centers
- suppression of renin activity and
- vasodilation and decreased peripheral vascular resistance
Absorption and Distribution: Absorption of Nebivolol is similar to an oral solution. Mean peak plasma nebivolol concentrations occur approximately 1.5 to 4 hours post-dosing in EMs and PMs. Food does not alter the pharmacokinetics of nebivolol. Nebivolol may be administered without regard to meals. The in vitro human plasma protein binding of nebivolol is approximately 98%, mostly to albumin, and is independent of nebivolol concentrations.
Metabolism and Excretion: Nebivolol is predominantly metabolized via direct glucuronidation of parent and to a lesser extent via N-dealkylation and oxidation via cytochrome P450 2D6. After a single oral administration of 14C-nebivolol, 38% of the dose was recovered in urine and 44% in feces for EMs and 67% in urine and 13% in feces for PMs.
Digoxin: Concomitant administration of Nebivolol (10 mg once daily) and digoxin (0.25 mg once daily) for 10 days in 14 healthy adult individuals resulted in no significant changes in the pharmacokinetics of digoxin or nebivolol.
Warfarin: Administration of Nebivolol (10 mg once daily for 10 days) led to no significant changes in the pharmacokinetics of nebivolol or R- or S-warfarin following a single 10 mg dose of warfarin. Similarly, nebivolol has no significant effects on the anticoagulant activity of warfarin, as assessed by Prothrombin time and INR profiles from 0 to 144 hours after a single 10 mg warfarin dose in 12 healthy adult volunteers. The starting dose should be reduced in patients with moderate hepatic impairment. No formal studies have been performed in patients with severe hepatic impairment and nebivolol should be contraindicated for these patients.
DosageView
The dose of Nebivolol should be individualized to the needs of the patient. For most patients, the recommended starting dose is 5 mg once daily, with or without food, as monotherapy or in combination with other agents. For patients requiring further reduction in blood pressure, the dose can be increased at 2-week intervals up to 40 mg. A more frequent dosing regimen is unlikely to be beneficial.
Side effectsView
Headache, nausea and bradycardia.
ContraindicationsView
Nebivolol is contraindicated in patients with severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), or severe hepatic impairment (Child-Pugh >B), and in patients who are hypersensitive to any component of this product.
PrecautionsView
Abrupt Cessation of Therapy: Patients with coronary artery disease treated with Nebivolol should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with β-blockers. Myocardial infarction and ventricular arrhythmias may occur with or without preceding exacerbation of the angina pectoris. Even patients without overt coronary artery disease should be cautioned against interruption or abrupt discontinuation of therapy. As with other β-blockers, when discontinuation of Nebivolol is planned, patients should be carefully observed and advised to minimize physical activity. Nebivolol should be tapered over 1 to 2 weeks when possible. If the angina worsens or acute coronary insufficiency develops, it is recommended that Nebivolol be promptly reinstituted, at least temporarily.
Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure, and (β-blockade may result in further depression of myocardial contractility and precipitate more severe failure. In patients who have compensated congestive heart failure, Nebivolol should be administered cautiously. If heart failure worsens, discontinuation of Nebivolol should be considered.
Angina and Acute Myocardial Infarction: Nebivolol was not studied in patients with angina pectoris or who had a recent Ml.
Bronchospastic Diseases: In general, patients with bronchospastic diseases should not receive (3-blockers.
Anesthesia and Major Surgery: If Nebivolol is to be continued perioperatively, patients should be closely monitored when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used. If β-blocking therapy is withdrawn prior to major surgery, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. The β-blocking effects of Nebivolol can be reversed by β-agonists, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Additionally, difficulty in restarting and maintaining the heartbeat has been reported with (β-blockers).
Diabetes and Hypoglycemia: β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective β-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. It is not known whether nebivolol has these effects. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be advised about these possibilities and nebivolol should be used with caution.
Thyrotoxicosis: β-blockers may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of β-blockers may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate a thyroid storm.
Peripheral Vascular Disease: β-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in these patients.
Non-dihydropyridine Calcium Channel Blockers: Because of significant negative inotropic and chronotropic effects in patients treated with β-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be used in patients treated concomitantly with these agents and ECG and blood pressure should be monitored.
Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure, and (β-blockade may result in further depression of myocardial contractility and precipitate more severe failure. In patients who have compensated congestive heart failure, Nebivolol should be administered cautiously. If heart failure worsens, discontinuation of Nebivolol should be considered.
Angina and Acute Myocardial Infarction: Nebivolol was not studied in patients with angina pectoris or who had a recent Ml.
Bronchospastic Diseases: In general, patients with bronchospastic diseases should not receive (3-blockers.
Anesthesia and Major Surgery: If Nebivolol is to be continued perioperatively, patients should be closely monitored when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used. If β-blocking therapy is withdrawn prior to major surgery, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. The β-blocking effects of Nebivolol can be reversed by β-agonists, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Additionally, difficulty in restarting and maintaining the heartbeat has been reported with (β-blockers).
Diabetes and Hypoglycemia: β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective β-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. It is not known whether nebivolol has these effects. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be advised about these possibilities and nebivolol should be used with caution.
Thyrotoxicosis: β-blockers may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of β-blockers may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate a thyroid storm.
Peripheral Vascular Disease: β-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in these patients.
Non-dihydropyridine Calcium Channel Blockers: Because of significant negative inotropic and chronotropic effects in patients treated with β-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be used in patients treated concomitantly with these agents and ECG and blood pressure should be monitored.
InteractionsView
Nebivolol should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently. Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Nebivolol should not be combined with other β-blockers. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored, because the added β-blocking action of Nebivolol may produce excessive reduction of sympathetic activity. In patients who are receiving Nebivolol and clonidine, Nebivolol should be discontinued for several days before the gradual tapering of clonidine.
CYP2D6 Inhibitors: Use caution when Nebivolol is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)
Nebivolol should not be combined with other β-blockers. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored, because the added β-blocking action of Nebivolol may produce excessive reduction of sympathetic activity. In patients who are receiving Nebivolol and clonidine, Nebivolol should be discontinued for several days before the gradual tapering of clonidine.
CYP2D6 Inhibitors: Use caution when Nebivolol is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)
Pediatric usageView
Impaired Renal Function: Nebivolol should be used with caution in patients with severe renal impairment because of decreased renal clearance. Nebivolol has not been studied in patients receiving dialysis.
Impaired Hepatic Function: Nebivolol should be used with caution in patients with moderate hepatic impairment because of decreased metabolism. Since Nebivolol has not been studied in patients with severe hepatic impairment, Nebivolol is contraindicated in this population.
Risk of Anaphylactic Reactions: While taking β-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenges either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
Impaired Hepatic Function: Nebivolol should be used with caution in patients with moderate hepatic impairment because of decreased metabolism. Since Nebivolol has not been studied in patients with severe hepatic impairment, Nebivolol is contraindicated in this population.
Risk of Anaphylactic Reactions: While taking β-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenges either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Ivrenas
Favipiravir
Ivrenas
Favipiravir
Indications
Influenza
Indication detailsView
Treatment of novel or re-emerging pandemic influenza virus infections (limited to cases in which other influenza antiviral drugs are ineffective or not sufficiently effective).
Therapeutic classView
Anti-viral drugs
PharmacologyView
Favipiravir is a new antiviral drug against influenza. It is metabolized into favipiravir ribosyl triphosphate (favipiravir RTP) by an intracellular enzyme, and favipiravir RTP selectively inhibits RNA polymerase (RNA-dependent RNA polymerase) of the influenza virus, preventing replication of the influenza virus. It is a drug with a mechanism of action different from that of the existing influenza antiviral drugs and effective against all types and sub-types of human influenza A, B, and C viruses in vitro, showing a wide range of anti-viral activity against various influenza virus strains including avian and swine viruses.
DosageView
The usual adult dosage is 1600 mg of Favipiravir administered orally twice daily on Day 1, followed by 600 mg orally twice daily from Day 2 to Day 5 or as directed by physicians. The total treatment duration should be 5 days.
Side effectsView
Most common side effects are Diarrhea and increase of blood uric acid levels.
ContraindicationsView
Favipiravir is contraindicated for pregnant women and women who may possibly be pregnant.
PrecautionsView
Favipiravir should not be given in pregnant women, requirement of the confirmation of non-pregnancy in women of childbearing potential before use, thorough contraception measures from the start of the treatment to 7 days after the end of the treatment. Caution should be taken for Hepatic and renal impaired patient or use Favipiravir as per the direction of registered Physician
InteractionsView
In animal studies, decreased RBC production,and increases in liver function parameters such as AST, ALP, ALT and total bilirubin, and increased vacuolization in hepatocytes. Toxicity information regarding Favipiravir in humans is not readily available.
Pregnancy & lactationView
Favipiravir may cause delayed development or death of embryos during the early stage of pregnancy. Should not be given during pregnancy.
Pediatric usageView
This drug is only approved as an experimental drug and still a lot of studies is needed about it’s efficacy and also toxic reactions and use in children.
Overdose effectsView
In animal studies, decreased RBC production,and increases in liver function parameters such as AST, ALP, ALT and total bilirubin, and increased vacuolization in hepatocytes. Toxicity information regarding Favipiravir in humans is not readily available.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
Izic
Carbonyl Iron + Folic Acid + Zinc Sulfate
Izic
Carbonyl Iron + Folic Acid + Zinc Sulfate
Indications
Pregnancy
Indication detailsView
It is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.
Therapeutic classView
Iron, Vitamin & Mineral Combined preparation
PharmacologyView
This timed-release capsule is the combined preparation of Carbonyl Iron, Folic Acid and Zinc Sulphate Monohydrate. It contains Carbonyl Iron with not less than 98% Iron content. Carbinyl Iron, having high bioavailability and low toxicity is safer and more effective choice for iron supplementation.
DosageView
Adult: One Capsule daily before food or as directed by the physician.
Side effectsView
Gastrointestinal irritations such as nausea, anorexia, vomiting, discomfort, constipation and diarrhoea may occur. Patients may complain of dark stool. Carbonyl Iron pellets incorporated into the capsules to reduce the possibility of gastrointestinal irritations. Rarely there may be allergic reactions.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to any of its component or those with Iron overload.
PrecautionsView
Special care should be taken in patients with Iron overload states, such as haemochromatosis, haemolytic anaemia or red blood cell aplasia. Failure to response to the treatment requires further investigations to exclude other causes of anaemia. In patients with renal failure there may be the risk of Zinc accumulation.
InteractionsView
Carbonyl Iron decreases the absorption of tetracycline antibiotics, quinolone antibiotics, levodopa, levothyroxine, methyldopa and penecillamine. Folic Acid interacts with antiepileptics, so plasma concentrations of phenobarbital, phenytoin and primidone are possibly reduced.
Pregnancy & lactationView
Use of any drug during first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency. Prophylaxis of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of pregnancy.
Overdose effectsView
Symptoms of Carbonyl Iron include decreased energy, nausea, abdominal pain, tarry stool, weak, rapid pulse, fever, coma, seizures.
StorageView
Store below 30°C. and keep away from light and moisture. Keep all medicines out of the reach of children.
J-Mox
Amoxicillin Trihydrate
J-Mox
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
J-Mox
Amoxicillin Trihydrate
J-Mox
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
J-Mox
Amoxicillin Trihydrate
J-Mox
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
J-Mox
Amoxicillin Trihydrate
J-Mox
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
J-Zinc
Zinc Sulfate Monohydrate
J-Zinc
Zinc Sulfate Monohydrate
Indications
Zinc deficiency
Indication detailsView
Zinc Sulfate Monohydrate is indicated in zinc deficiency and/or zinc losing conditions. Zinc deficiency can occur as a result of inadequate diet or malabsorption. Excessive loss of zinc can occur in trauma, burns, diarrhoea and protein losing conditions. A zinc supplement is given until clinical improvement occurs but it may need to be continued in severe malabsorption, metabolic disease or in zinc losing states.
Therapeutic classView
Specific mineral preparations
PharmacologyView
Zinc sulphate monohydrate is an essential trace element and is involved in a number of body enzyme systems. The body needs zinc for normal growth and health. Zinc is also vital for sexual maturation and reproduction, dark vision adaptation, olfactory and gustatory activity, insulin storage & release and for a variety of host immune defenses. Zinc deficiency may lead to impaired immune function, delayed wound healing, a decrease in sense of taste and smell, a reduced ability to fight infections, poor night vision, increased risk of abortion, alopecia, mental lethargy, skin changes and poor development of reproductive organs.
DosageView
Child under 10 kg: 5 ml (1 teaspoonful) 2 times daily after food.
Child between 10-30 kg: 10 ml (2 teaspoonfuls) 1-3 times daily after food.
Adults and child over 30 kg: 20 ml (4 teaspoonfuls) 1-3 times daily after food.
This drug is most effective if they are taken at least 1 hour before or 2 hour after meals. However, if causes stomach upset, this may be taken with a meal.
Child between 10-30 kg: 10 ml (2 teaspoonfuls) 1-3 times daily after food.
Adults and child over 30 kg: 20 ml (4 teaspoonfuls) 1-3 times daily after food.
This drug is most effective if they are taken at least 1 hour before or 2 hour after meals. However, if causes stomach upset, this may be taken with a meal.
AdministrationView
For dispersible tablet-
- Place the tablet in a teaspoon
- Add adequate amount of water
- Let the tablet dissolve completely
- Give the entire spoonful solution
Side effectsView
Zinc may cause nausea, vomiting, diarrhoea, stomach upset, heartburn and gastritis.
ContraindicationsView
It is contraindicated in those who are hypersensitive to any component of the ingredient of this preparation.
PrecautionsView
In acute renal failure, zinc accumulation may occur in body; so dose adjustment is needed.
InteractionsView
Concomitant intake of a tetracycline and zinc may decrease the absorption of both the tetracycline and zinc. Similarly concomitant administration of zinc and quinolone drug may also decrease the absorption of both. Concomitant intake of penicillamine and zinc may decrese absorption of zinc.
Pregnancy & lactationView
The safety of this product in human pregnancy has not been established. Zinc crosses the placenta and is present in breast milk.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Jafa
Ondansetron
Jafa
Ondansetron
Indications
Post-operative nausea and vomiting
Indication detailsView
Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated:
- Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
- Prevention and treatment of post-operative nausea and vomiting.
- Prevention of radiotherapy-induced nausea and vomiting.
Therapeutic classView
Anti-emetic drugs
PharmacologyView
Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.
DosageView
Chemotherapy-Induced Nausea and Vomiting-
Adults, Pediatric patients (6 months to 18 years):
Adults:
Adults:
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:
Adults, Pediatric patients (6 months to 18 years):
- 8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Adults:
- 8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
- 4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
- Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Adults:
- 8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets
- 4 mg orodispersible tablet: 16 mg
- Injection: 4 mg
Pediatrics (40 kg): Injection: 0.1 mg/kg
Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
- Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy.
- Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml dose should be administered after 8 hours of the first dose. One 10 ml dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.
Oral solution:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):- The recommended oral dosage: 10 ml (8 mg) Ondansetron Oral Solution 3 times daily.
- For total body irradiation: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
- For single high-dose fraction radiotherapy to the abdomen: one 10 ml Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
- For daily fractionated radiotherapy to the abdomen: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
- 20 ml (16 mg) Ondansetron Oral Solution 1 hour before induction of anesthesia
Oral Soluble Film:
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:- Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.
- Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
- Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
- Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
- Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.
AdministrationView
Administration of Oral Soluble Film:
- Step 1: Tear the pouch carefully along with the edge tear mark.
- Step 2: Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds
- Step 3: Do not chew or swallow the film whole.
- Step 4: Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid.
- Step 5: Wash your hands after taking Onsaf oral soluble film
Side effectsView
Frequently reported adverse events were headache, constipation and diarrhea, but the majority have been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There have been no evidence to extrapyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definitive clinical evidence. In case of PONV, with the exception of headache, rates of these events were not significantly different in the Ondansetron and placebo groups.
ContraindicationsView
Contraindicated in patients known to have hypersensitivity to the drug or any of its components. Concomitant use of apomorphine.
PrecautionsView
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.
InteractionsView
Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment of Ondasetron is recommended for patients on these drugs.
Pregnancy & lactationView
Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.
Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.
Pediatric usageView
Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population.
Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.
4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.
Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.
Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.
4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.
Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.
StorageView
Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.
Jakavi
Ruxolitinib
Jakavi
Ruxolitinib
Indications
Polycythaemia vera
Indication detailsView
Myelofibrosis: Ruxolitinib is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults.
Polycythemia Vera: Ruxolitinib is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
Acute Graft-Versus-Host Disease: Ruxolitinib is indicated for treatment of steroid-refractory acute graft-versus host disease (GVHD) in adult and pediatric patients 12 years and older.
Polycythemia Vera: Ruxolitinib is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
Acute Graft-Versus-Host Disease: Ruxolitinib is indicated for treatment of steroid-refractory acute graft-versus host disease (GVHD) in adult and pediatric patients 12 years and older.
Therapeutic classView
Pyrrolopyrimidines
PharmacologyView
Ruxolitinib, a kinase inhibitor, inhibits Janus Associated Kinases (JAKs) JAK1 and JAK2 which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation and subsequent localization of STATs to the nucleus leading to modulation of gene expression. Myelofibrosis (MF) is a myeloproliferative neoplasm (MPN) known to be associated with dysregulated JAK1 and JAK2 signaling. Oral administration of ruxolitinib prevented splenomegaly, preferentially decreased JAK2V617F mutant cells in the spleen and decreased circulating inflammatory cytokines (eg, TNF-α, IL-6).
Absorption: Ruxolitinib is rapidly absorbed after oral Ruxolitinib administration with maximal plasma concentration (Cmax) achieved within 1 to 2 hours post-dose. Oral absorption of ruxolitinib was estimated to be at least 95%. Distribution: The mean volume of distribution of ruxolitinib at steady-state is 72 L in patient with MF and PV in myelofibrosis patients.
Half-life: the mean half-life of ruxolitinib & metabolites is approximately 5.8 hours. Elimination half-life: The mean elimination half-life of ruxolitinib is approximately 3 hours AUC: Mean ruxolitinib Cmax and total exposure (AUC) increased proportionally over a single dose range of 5 to 200 mg.
The plasma protein binding: 97%, mostly to albumin. Metabolism: Ruxolitinib is metabolized by CYP3A4 and to a lesser extent by CYP2C9.
Excretion: Following a single oral dose of radio labeled ruxolitinib in healthy adult subjects, elimination was predominately through metabolism with 74% of radioactivity excreted in urine and 22% excretion via feces. Unchanged drug accounted for less than 1% of the excreted total radioactivity.
Absorption: Ruxolitinib is rapidly absorbed after oral Ruxolitinib administration with maximal plasma concentration (Cmax) achieved within 1 to 2 hours post-dose. Oral absorption of ruxolitinib was estimated to be at least 95%. Distribution: The mean volume of distribution of ruxolitinib at steady-state is 72 L in patient with MF and PV in myelofibrosis patients.
Half-life: the mean half-life of ruxolitinib & metabolites is approximately 5.8 hours. Elimination half-life: The mean elimination half-life of ruxolitinib is approximately 3 hours AUC: Mean ruxolitinib Cmax and total exposure (AUC) increased proportionally over a single dose range of 5 to 200 mg.
The plasma protein binding: 97%, mostly to albumin. Metabolism: Ruxolitinib is metabolized by CYP3A4 and to a lesser extent by CYP2C9.
Excretion: Following a single oral dose of radio labeled ruxolitinib in healthy adult subjects, elimination was predominately through metabolism with 74% of radioactivity excreted in urine and 22% excretion via feces. Unchanged drug accounted for less than 1% of the excreted total radioactivity.
DosageView
Myclofibrosis: The recommended starting dose of Ruxolitinib is based on platelet count. A complete blood count (CBC) and platelet count must be performed before initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as clinically indicated. Doses may be titrated based on safety and efficacy.
Acute Graft-Versus-Host Disease: The recommended dose of Ruxolitinib is 5 mg twice daily. Consider increasing the dose to 10 mg twice daily after at least 3 days of treatment if the ANC and platelet counts are not decreased by 50% or more relative to the first day of dosing with ruxolitinib. Or as directed by the registered physician.
- Platelet count greater than 200 X 10 9 /L: Starting dose 20 mg orally twice daily.
- Platelet count 100 X 10 9 /L to 200 X 10 9 /L: Starting dose 15 mg orally twice daily.
- Platelet count 50 X 10 9 /L to less than 100 X 10 9 /L: Starting dose 5 mg orally twice daily.
Acute Graft-Versus-Host Disease: The recommended dose of Ruxolitinib is 5 mg twice daily. Consider increasing the dose to 10 mg twice daily after at least 3 days of treatment if the ANC and platelet counts are not decreased by 50% or more relative to the first day of dosing with ruxolitinib. Or as directed by the registered physician.
AdministrationView
Ruxolitinib is to be taken orally, with or without food. If a dose is missed, the patient should not take an additional dose, but should take the next usual prescribed dose.
Side effectsView
The most common side effects are-
- Thrombocytopenia, Anemia and Neutropenia
- Risk of Infection, bruising, dizziness, headache
- Symptom Exacerbation Following Interruption or Discontinuation of treatment with Ruxolitinib
- Non-Melanoma Skin Cancer
ContraindicationsView
It is contraindicated in patients with a history of hypersensitivity to Ruxolitinib or any other components of this product.
PrecautionsView
Thrombocytopenia, Anemia And Neutropenia: Treatment with Ruxolitinib can cause thrombocytopenia, anemia and neutropenia. Manage thrombocytopenia by reducing the dose or temporarily interrupting Ruxolitinib. Platelet transfusions may be necessary.Patients developing anemia may require blood transfusions and/or dose modifications of Ruxolitinib.Severe neutropenia (ANC less than 0.5 X 109/L) was generally reversible by withholding Ruxolitinib until recovery.Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated.
Risk of Infection: Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting therapy with Ruxolitinib until active serious infections have resolved. Observe patients receiving Ruxolitinib for signs and symptoms of infection and manage promptly.
Tuberculosis: Tuberculosis infection has been reported in patients receiving Ruxolitinib. Observe patients receiving Ruxolitinib for signs and symptoms of active tuberculosis and manage promptly. Prior to initiating Ruxolitinib, patients should be evaluated for tuberculosis risk factors, and those at higher risk should be tested for latent infection. Risk factors include, but are not limited to, prior residence in or travel to countries with a high prevalence of tuberculosis, close contact with a person with active tuberculosis, and a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed. For patients with evidence of active or latent tuberculosis, consult a physician with expertise in the treatment of tuberculosis before starting Ruxolitinib. The decision to continue Ruxolitinib during treatment of active tuberculosis should be based on the overall risk-benefit determination.
Progressive Multifocal Leukoencephalopathy: Progressive multifocal leukoencephalopathy (PML) has occurred with Ruxolitinib treatment. If PML is suspected, stop Ruxolitinib and evaluate.
Herpes Zoster: Advise patients about early signs and symptoms of herpes zoster and to seek treatment as early as possible if suspected.
Hepatitis B: Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking Ruxolitinib. The effect of Ruxolitinib on viral replication in patients with chronic HBV infection is unknown. Patients with chronic HBV infection should be treated and monitored according to clinical guidelines.
Symptom Exacerbation Following Interruption or Discontinuation Of Treatment With Ruxolitinib: Following discontinuation of Ruxolitinib, symptoms from myeloproliferative neoplasms may return to pretreatment levels over a period of approximately one week. Some patients with MF have experienced one or more of the following adverse events after discontinuing Ruxolitinib: fever, respiratory distress, hypotension, DIC, or multi organ failure. If one or more of these occur after discontinuation of, or while tapering the dose of Ruxolitinib, evaluate for and treat any intercurrent illness and consider restarting or increasing the dose of Ruxolitinib. Instruct patients not to interrupt or discontinue Ruxolitinib therapy without consulting their physician. When discontinuing or interrupting therapy with Ruxolitinib for reasons other than thrombocytopenia or neutropenia, consider tapering the dose of Ruxolitinib gradually rather than discontinuing abruptly.
Non-Melanoma Skin Cancer: Non-melanoma skin cancers including basal cell, squamous cell, and Merkel cell carcinoma have occurred in patients treated with Ruxolitinib. Perform periodic skin examinations.
Lipid Elevations: Treatment with Ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined in patients treated with Ruxolitinib. Assess lipid parameters approximately 8-12 weeks following initiation of Ruxolitinib therapy. Monitor and treat according to clinical guidelines for the management of hyperlipidemia.
Risk of Infection: Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting therapy with Ruxolitinib until active serious infections have resolved. Observe patients receiving Ruxolitinib for signs and symptoms of infection and manage promptly.
Tuberculosis: Tuberculosis infection has been reported in patients receiving Ruxolitinib. Observe patients receiving Ruxolitinib for signs and symptoms of active tuberculosis and manage promptly. Prior to initiating Ruxolitinib, patients should be evaluated for tuberculosis risk factors, and those at higher risk should be tested for latent infection. Risk factors include, but are not limited to, prior residence in or travel to countries with a high prevalence of tuberculosis, close contact with a person with active tuberculosis, and a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed. For patients with evidence of active or latent tuberculosis, consult a physician with expertise in the treatment of tuberculosis before starting Ruxolitinib. The decision to continue Ruxolitinib during treatment of active tuberculosis should be based on the overall risk-benefit determination.
Progressive Multifocal Leukoencephalopathy: Progressive multifocal leukoencephalopathy (PML) has occurred with Ruxolitinib treatment. If PML is suspected, stop Ruxolitinib and evaluate.
Herpes Zoster: Advise patients about early signs and symptoms of herpes zoster and to seek treatment as early as possible if suspected.
Hepatitis B: Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking Ruxolitinib. The effect of Ruxolitinib on viral replication in patients with chronic HBV infection is unknown. Patients with chronic HBV infection should be treated and monitored according to clinical guidelines.
Symptom Exacerbation Following Interruption or Discontinuation Of Treatment With Ruxolitinib: Following discontinuation of Ruxolitinib, symptoms from myeloproliferative neoplasms may return to pretreatment levels over a period of approximately one week. Some patients with MF have experienced one or more of the following adverse events after discontinuing Ruxolitinib: fever, respiratory distress, hypotension, DIC, or multi organ failure. If one or more of these occur after discontinuation of, or while tapering the dose of Ruxolitinib, evaluate for and treat any intercurrent illness and consider restarting or increasing the dose of Ruxolitinib. Instruct patients not to interrupt or discontinue Ruxolitinib therapy without consulting their physician. When discontinuing or interrupting therapy with Ruxolitinib for reasons other than thrombocytopenia or neutropenia, consider tapering the dose of Ruxolitinib gradually rather than discontinuing abruptly.
Non-Melanoma Skin Cancer: Non-melanoma skin cancers including basal cell, squamous cell, and Merkel cell carcinoma have occurred in patients treated with Ruxolitinib. Perform periodic skin examinations.
Lipid Elevations: Treatment with Ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined in patients treated with Ruxolitinib. Assess lipid parameters approximately 8-12 weeks following initiation of Ruxolitinib therapy. Monitor and treat according to clinical guidelines for the management of hyperlipidemia.
InteractionsView
Fluconazole: Concomitant administration of Ruxolitinib with fluconazole greater than 200 mg daily may increase ruxolitinib exposure due to inhibition of both the CYP3A4 and CYP2C9 metabolic pathways. Increased exposure may increase the risk of exposure-related adverse reactions. Avoid the concomitant use of Ruxolitinib with fluconazole doses of greater than 200 mg daily except in patients with acute GVHD.
Strong CYP3A4 Inhibitors: Concomitant administration of Ruxolitinib with strong CYP3A4 inhibitors increases ruxolitinib exposure. Increased exposure may increase the risk of exposure-related adverse reactions. Consider dose reduction when administering Ruxolitinib with strong CYP3A4 inhibitors. In patients with acute GVHD, reduce Ruxolitinib dose as recommended only when coadministered with ketoconazole, and monitor blood counts more frequently for toxicity and adjust the dose if necessary when coadministered with itraconazole.
Strong CYP3A4 Inducers: Concomitant administration of Ruxolitinib with strong CYP3A4 inducers may decrease ruxolitinib exposure. No dose adjustment is recommended; however, monitor patients frequently and adjust the Ruxolitinib dose based on safety and efficacy.
Strong CYP3A4 Inhibitors: Concomitant administration of Ruxolitinib with strong CYP3A4 inhibitors increases ruxolitinib exposure. Increased exposure may increase the risk of exposure-related adverse reactions. Consider dose reduction when administering Ruxolitinib with strong CYP3A4 inhibitors. In patients with acute GVHD, reduce Ruxolitinib dose as recommended only when coadministered with ketoconazole, and monitor blood counts more frequently for toxicity and adjust the dose if necessary when coadministered with itraconazole.
Strong CYP3A4 Inducers: Concomitant administration of Ruxolitinib with strong CYP3A4 inducers may decrease ruxolitinib exposure. No dose adjustment is recommended; however, monitor patients frequently and adjust the Ruxolitinib dose based on safety and efficacy.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. It is not known whether Ruxolitinib is excreted in human milk. Because many drugs are excreted in human milk, breastfeeding should be discontinued during treatment with Ruxolitinib and for two weeks after the final dose.
Pediatric usageView
Use in children: The safety and effectiveness of Ruxolitinib in pediatric patients have not been established.
Overdose effectsView
There is no known antidote for overdoses with Ruxolitinib. Single doses up to 200 mg have been given with acceptable acute tolerability. Higher than recommended repeat doses are associated with increased myelosuppression including leukopenia, anemia and thrombocytopenia. Appropriate supportive treatment should be given. Hemodialysis is not expected to enhance the elimination of Ruxolitinib.
StorageView
Store below 30°C in a dry place, away from sunlight. Keep out of reach of children.
Jakloc
Tofacitinib
Jakloc
Tofacitinib
Indications
Ulcerative colitis
Indication detailsView
Rheumatoid Arthritis: Tofacitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
Psoriatic Arthritis: Tofacitinib is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
Ulcerative Colitis: Tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
Psoriatic Arthritis: Tofacitinib is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
Ulcerative Colitis: Tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
Therapeutic classView
Immunosuppressant
PharmacologyView
Rheumatoid arthritis is an autoimmune disease characterized by a dysregulation of pro-inflammatory cytokines including IL7, IL15, IL21, IL6, IFN-alpha, and IFN-beta. (3) Cytokines signalling results in tissue inflammation and joint damage by stimulating the recruitment and activation of immune cells via the janus kinase signalling pathway.
Tofacitinib is a partial and reversible janus kinase (JAK) inihibitor that will prevent the body from responding to cytokine signals. By inhibiting JAKs, tofacitinib prevents the phosphorylation and activation of STATs. The JAK-STAT signalling pathway is involved in the transcription of cells involved in hematopoiesis, and immune cell function. Tofacitinib works therapeutically by inhibiting the JAK-STAT pathway to decrease the inflammatory response. However, there is evidence to suggest that it may also achieve efficacy via other pathways as well.
Tofacitinib is a partial and reversible janus kinase (JAK) inihibitor that will prevent the body from responding to cytokine signals. By inhibiting JAKs, tofacitinib prevents the phosphorylation and activation of STATs. The JAK-STAT signalling pathway is involved in the transcription of cells involved in hematopoiesis, and immune cell function. Tofacitinib works therapeutically by inhibiting the JAK-STAT pathway to decrease the inflammatory response. However, there is evidence to suggest that it may also achieve efficacy via other pathways as well.
DosageView
Rheumatoid Arthritis: Tofacitinib 5 mg twice daily or Tofacitinib 11 mg once daily. Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofacitinib 5 mg once daily.
Psoriatic Arthritis (in combination with nonbiologic DMARDs): Tofacitinib 5 mg twice daily or Tofacitinib 11 mg once daily. Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofacitinib 5 mg once daily.
Ulcerative Colitis: Tofacitinib 10 mg twice daily for at least 8 weeks; then 5 or 10 mg twice daily. Discontinue after 16 weeks of 10 mg twice daily, if adequate therapeutic benefit is not achieved. Use the lowest effective dose to maintain response.
Psoriatic Arthritis (in combination with nonbiologic DMARDs): Tofacitinib 5 mg twice daily or Tofacitinib 11 mg once daily. Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofacitinib 5 mg once daily.
Ulcerative Colitis: Tofacitinib 10 mg twice daily for at least 8 weeks; then 5 or 10 mg twice daily. Discontinue after 16 weeks of 10 mg twice daily, if adequate therapeutic benefit is not achieved. Use the lowest effective dose to maintain response.
Side effectsView
The most commonly reported adverse reactions during the first 3 months in controlled clinical trials (occurring in greater than or equal to 2% of patients treated with Tofacitinib monotherapy or in combination with DMARDs) were upper respiratory tract infections, headache, diarrhea and nasopharyngitis.
PrecautionsView
- Serious Infections: Avoid use of Tofacitinib during an active serious infection, including localized infections.
- Gastrointestinal Perforations: Use with caution in patients that may be at increased risk.
- Laboratory Monitoring: Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids.
- Immunizations: Live vaccines: Avoid use with Tofacitinib.
- Do not initiate Tofacitinib if absolute lymphocyte count <500 cells/mm3, an absolute neutrophil count (ANC) <1000 cells/mm3 or hemoglobin <9 gm/dL.
InteractionsView
- Potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., Ketoconazole)
- Recommended dose is Tofacitinib 5 mg once daily: One or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole)
- Recommended dose is Tofacitinib 5 mg once daily Potent CYP inducers (e.g.Rifampin): May result in loss of or reduced clinical response.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. Tofacitinib should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Tofacitinib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Tofacitinib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug for the mother
It is not known whether Tofacitinib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Tofacitinib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug for the mother
Pediatric usageView
Pediatric Use: The safety and effectiveness of Tofacitinib in pediatric patients have not been established.
Geriatric Use: The frequency of serious infection among Tofacitinib-treated subjects 65 years of age and older was higher than among those under the age of 65. As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly.
Moderate and severe renal impairment or moderate hepatic impairment: half the total daily dosage recommended for patients with normal renal and hepatic function.
Geriatric Use: The frequency of serious infection among Tofacitinib-treated subjects 65 years of age and older was higher than among those under the age of 65. As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly.
Moderate and severe renal impairment or moderate hepatic impairment: half the total daily dosage recommended for patients with normal renal and hepatic function.
StorageView
Store below 30°C. Protect from light & moisture. Keep all medicines out of the reach of children.