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Xirom
Bromfenac Sodium
Xirom
Bromfenac Sodium
Indications
Postoperative ocular inflammation
Indication detailsView
Bromfenac is indicated for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract extraction
Therapeutic classView
Ophthalmic Non-Steroid drugs
PharmacologyView
Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID). The mechanism of anti-inflammatory activity is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis and increased intraocular pressure.
DosageView
Adults: 1 drop to the problem eye 2 times a day; treatment should start 24 hours after surgery and should continue for 2 weeks
Children: Use and dose must be determined by the doctor.
Pediatric Use: Safety and efficacy in pediatric patients below the age of 18 have not been established yet.
Children: Use and dose must be determined by the doctor.
Pediatric Use: Safety and efficacy in pediatric patients below the age of 18 have not been established yet.
Side effectsView
The most commonly reported adverse reactions following use of Bromfenac after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache and iritis. These events were reported in 2-7% of patients
ContraindicationsView
Bromfenac ophthalmic solution is contraindicated in patients with known hypersensitivity to any ingredients of the formulation.
PrecautionsView
All topical NSAIDs may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. It is recommended that Bromfenac ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Bromfenac ophthalmic solution should not be administered while wearing contact lenses.
Bromfenac ophthalmic solution contains Sodium Sulfite, a compound that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
Bromfenac ophthalmic solution contains Sodium Sulfite, a compound that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
Pregnancy & lactationView
Pregnancy Category C. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Bromfenac ophthalmic solution is administered to a nursing mother.
StorageView
Keep out of the reach of children. Store in a cool, dry place, away from heat and direct light. Do not use more than 4 weeks after opening.
Xisol
Chlorhexidine Gluconate + Isopropyl alcohol
Xisol
Chlorhexidine Gluconate + Isopropyl alcohol
Indications
Preoperative hand disinfection
Indication detailsView
For the disinfection of clean and intact skin. For pre-operative surgical hand disinfection, hand disinfection on the ward prior to aseptic procedures or after handling contaminated materials. For disinfection of the patients’ skin prior to surgery or other invasive procedures
Therapeutic classView
Chlorhexidine & Chloroxylenol preparations
PharmacologyView
Chlorhexidine is a very potent cationic chemoprophylactic agent that has a broad-spectrum of activity against gm+ve and gm-ve bacteria. It is both bacteriostatic and bactericidal depending on its concentration. The bactericidal effect, which is achieved at high concentrations, is due to the binding of the cationic to negatively charged bacterial cell walls and extramicrobial complexes. Bacteriostatic effect is achieved at low concentrations which causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorus.
DosageView
Pre-operative surgical hand disinfection: Dispense 5 ml of solution and spread thoroughly over both hands and forearms, rubbing vigorously. When dry apply a further 5 ml and repeat the procedure.
Antiseptic hand disinfection on the ward: Dispense 3 ml of solution and spread thoroughly over the hands and wrists rubbing vigorously until dry.
Disinfection of patients skin: Prior to surgery apply the solution to a sterile swab and rub vigorously over the operation site for a minimum of 2 minutes. Chlorhexidine Gluconate is also used for preparation of the skin prior to invasive procedures such as venepuncture.
Antiseptic hand disinfection on the ward: Dispense 3 ml of solution and spread thoroughly over the hands and wrists rubbing vigorously until dry.
Disinfection of patients skin: Prior to surgery apply the solution to a sterile swab and rub vigorously over the operation site for a minimum of 2 minutes. Chlorhexidine Gluconate is also used for preparation of the skin prior to invasive procedures such as venepuncture.
Side effectsView
Irritative skin reactions can occasionally occur. Generalised allergic reactions have also been reported but are extremely rare
ContraindicationsView
Chlorhexidine Gluconate is contraindicated for persons who have previously shown a hypersensitivity reaction to chlorhexidine. However, such reactions are extremely rare.
PrecautionsView
Avoid contact with brain, meninges, middle ear or sensitive tissues and eyes. Do not inject or use in body cavities.
InteractionsView
Chlorhexidine is incompatible with soaps and other anionic agents. Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with chlorhexidine solutions.
Pregnancy & lactationView
No untoward effects are known
Overdose effectsView
Symptoms: Pharyngeal oedema, necrotic lesions of the esophagus and elevated serum aminotransferase concentrations.
Management: Gastric lavage using milk, raw egg, gelatin or mild soap, or employ appropriate supportive measures.
Management: Gastric lavage using milk, raw egg, gelatin or mild soap, or employ appropriate supportive measures.
StorageView
Do not store above 25° C.
Xisrol
Bisoprolol Hemifumarate
Xisrol
Bisoprolol Hemifumarate
Indications
Hypertension
Indication detailsView
Bisoprolol is indicated in-
- Hypertension
- Angina
- Moderate to severe heart failure
Therapeutic classView
Anti adrenergic agent (Beta blockers), Beta-adrenoceptor blocking drugs, Beta-blockers
PharmacologyView
Bisoprolol Hemifumarate is the most selective ß1 blocker. It displays highest level of affinity for the ß1 receptor than any other beta-blocker available up to now. Selectively blocks ß1 adrenergic receptor in the heart and vascular smooth muscle and reduces heart rate and cardiac output resulting in decrease of arterial hypertension. Lipid metabolism can be adversely affected by ß-blockers, in patients with non-ß1 selective ß1-blocker, but Bisoprolol does not cause any change in the cholesterol fraction including the cardioprotective HDL-cholesterol, in long-term therapy.
DosageView
Adult: In the treatment of mild to moderate hypertension, Bisoprolol fumarate must be individualized to the needs of the patient. The usual starting dose is 5 mg once daily either added to a diuretic or alone. If the response to 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily. An appropriate interval for dose titration is 2 weeks. Increasing the dose beyond 20 mg once daily produces only a small incremental benefit.
Children: Safety and effectiveness in children have not been established.
Patients With Renal or Hepatic Impairment: In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 mL/min) as in other patients, the initial daily dose should be 5 mg. Because of the possibility of accumulation, caution must be used in dose titration. Since limited data suggest that bisoprolol fumarate is not dialysable, drug replacement is not necessary in patients undergoing dialysis.
Geriatrics: In the elderly, it is not usually necessary to adjust the dose, unless there is also significant renal or hepatic dysfunction
Children: Safety and effectiveness in children have not been established.
Patients With Renal or Hepatic Impairment: In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 mL/min) as in other patients, the initial daily dose should be 5 mg. Because of the possibility of accumulation, caution must be used in dose titration. Since limited data suggest that bisoprolol fumarate is not dialysable, drug replacement is not necessary in patients undergoing dialysis.
Geriatrics: In the elderly, it is not usually necessary to adjust the dose, unless there is also significant renal or hepatic dysfunction
Side effectsView
Bisoprolol, like any medication, may have some side effects. It is important that you keep your doctor informed of all side effects especially if you experience one of the following for several days. The most common side effects, whether or not caused by Bisoprolol, are: headache, fatigue, urinary tract infection, rhinitis or sinusitis (inflammation in the nose), diarrhea, dizziness, peripheral edema (swelling of the ankles), joint pain, cough, insomnia (trouble sleeping), nausea (feeling like vomiting), and sore throat. You must seek medical attention immediately if you experience an allergic reaction with symptoms of rash, itching, swelling, dizziness or trouble breathing.
Medicines affect different people in different ways. Just because side effects have occurred in other patients does not mean you will get them. Discuss how you feel on Bisoprolol with your doctor or pharmacist. Do not stop or restart Bisoprolol on your own.
Medicines affect different people in different ways. Just because side effects have occurred in other patients does not mean you will get them. Discuss how you feel on Bisoprolol with your doctor or pharmacist. Do not stop or restart Bisoprolol on your own.
ContraindicationsView
In patients with cardiogenic shock, overt heart failure, second or third degree A-V block, right ventricular failure secondary to pulmonary hypertension and sinus bradycardia.
PrecautionsView
Monitoring of renal, hepatic and hematopoietic function should be performed at regular intervals during long-term treatment with bisoprolol.
InteractionsView
Other β-blocking Agents: Bisoprolol fumarate should not be combined with other β-blocking agents.
Catecholamine-Depleting Drugs: Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be monitored closely because the added β-adrenergic blocking action of bisoprolol fumarate may produce excessive reduction of sympathetic activity.
Centrally Active Antihypertensive Agents: β-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the β-blocker should be withdrawn several days before discontinuing clonidine. If replacing clonidine by β-blocker therapy, the introduction of β-blockers should be delayed for several days after clonidine administration has stopped (see also prescribing information for clonidine).
Antiarrhythmic Agents: Bisoprolol fumarate should be used with care when myocardial depressants or inhibitors of A-V conduction, such as certain calcium antagonists (particularly of the phenyl alkylamine (verapamil) and benzothiazepine (diltiazem) classes), or antiarrhythmic agents, such as disopyramide, are used concurrently.
Calcium Channel Blockers: Combined use of β-blockers and calcium channel blockers with negative inotropic effects can lead to prolongation of S-A and A-V conduction, particularly in patients with impaired ventricular function or conduction abnormalities. This may result in severe hypotension, bradycardia and cardiac failure.
Catecholamine-Depleting Drugs: Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be monitored closely because the added β-adrenergic blocking action of bisoprolol fumarate may produce excessive reduction of sympathetic activity.
Centrally Active Antihypertensive Agents: β-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the β-blocker should be withdrawn several days before discontinuing clonidine. If replacing clonidine by β-blocker therapy, the introduction of β-blockers should be delayed for several days after clonidine administration has stopped (see also prescribing information for clonidine).
Antiarrhythmic Agents: Bisoprolol fumarate should be used with care when myocardial depressants or inhibitors of A-V conduction, such as certain calcium antagonists (particularly of the phenyl alkylamine (verapamil) and benzothiazepine (diltiazem) classes), or antiarrhythmic agents, such as disopyramide, are used concurrently.
Calcium Channel Blockers: Combined use of β-blockers and calcium channel blockers with negative inotropic effects can lead to prolongation of S-A and A-V conduction, particularly in patients with impaired ventricular function or conduction abnormalities. This may result in severe hypotension, bradycardia and cardiac failure.
Pregnancy & lactationView
Pregnancy: Bisoprolol fumarate was not teratogenic in rats at doses up to 150 mg/kg/day, which is 375 times the maximum recommended human daily dose. Bisoprolol fumarate was fetotoxic (increased late resorptions) at 50 mg/kg/day and maternotoxic (decreased food intake and body-weight gain) at 150 mg/kg/day. Bisoprolol fumarate was not teratogenic in rabbits at doses up to 12.5 mg/kg/day, which is 31 times the maximum recommended human daily dose, but was embryolethal (increased early resorptions) at 12.5 mg/kg/day. There are no studies in pregnant women. Bisoprolol fumarate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Small amounts of bisoprolol fumarate (<2% of the dose) have been detected in the milk of lactating rats. It is not known whether this drug is excreted in human milk. If use of bisoprolol fumarate is considered essential, then mothers should stop nursing.
Lactation: Small amounts of bisoprolol fumarate (<2% of the dose) have been detected in the milk of lactating rats. It is not known whether this drug is excreted in human milk. If use of bisoprolol fumarate is considered essential, then mothers should stop nursing.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xitabin
Capecitabine
Xitabin
Capecitabine
Indications
Carcinoma of the colon or rectum
Indication detailsView
Capecitabine is a nucleoside metabolic inhibitor with antineoplastic activity indicated for:
- Adjuvant Colon Cancer: Patients with Dukes'C colon cancer.
- Metastatic Colorectal Cancer: First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred.
- Metastatic Breast Cancer: In combination with docetaxel after failure of prior anthracycline containing therapy.
- As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen.
Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Capecitabine is a preparation of Capecitabine, an orally-administered chemotherapeutic agent used in the treatment of cancers. Capecitabine is a prodrug, that is enzymatically converted to fluorouracil (antimetabolite) in the tumour, where it inhibits DNA synthesis and slows growth of tumour tissue.
Capecitabine is a prodrug that is selectively tumour-activated to its cytotoxic moiety, fluorouracil, by thymidine phosphorylase, an enzyme found in higher concentrations in many tumours compared to normal tissues or plasma. Fluorouracil is further metabolized to two active metabolites, 5-fluoro-2'-deoxyuridine 5-monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP), within normal and tumour cells. These metabolites cause cell injury by two different mechanisms. First, FdUMP and the folate cofactor, N5-10 methylenetetrahydrofolate, bind to thymidylate synthase (TS) to form a covalently bound ternary complex. This binding inhibits the formation of thymidylate from 2-deoxyuridylate. Thymidylate is the necessary precursor of thymidine triphosphate, which is essential for the synthesis of DNA, therefore a deficiency of this compound can inhibit cell division. Secondly, nuclear transcriptional enzymes can mistakenly incorporate FUTP in place of uridine triphosphate (UTP) during the synthesis of RNA. This metabolic error can interfere with RNA processing and protein synthesis through the production of fraudulent RNA.
Capecitabine is a prodrug that is selectively tumour-activated to its cytotoxic moiety, fluorouracil, by thymidine phosphorylase, an enzyme found in higher concentrations in many tumours compared to normal tissues or plasma. Fluorouracil is further metabolized to two active metabolites, 5-fluoro-2'-deoxyuridine 5-monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP), within normal and tumour cells. These metabolites cause cell injury by two different mechanisms. First, FdUMP and the folate cofactor, N5-10 methylenetetrahydrofolate, bind to thymidylate synthase (TS) to form a covalently bound ternary complex. This binding inhibits the formation of thymidylate from 2-deoxyuridylate. Thymidylate is the necessary precursor of thymidine triphosphate, which is essential for the synthesis of DNA, therefore a deficiency of this compound can inhibit cell division. Secondly, nuclear transcriptional enzymes can mistakenly incorporate FUTP in place of uridine triphosphate (UTP) during the synthesis of RNA. This metabolic error can interfere with RNA processing and protein synthesis through the production of fraudulent RNA.
DosageView
Monotherapy: 1250 mg/m2 twice daily orally for 2 weeks followed by a one-week rest period in 3-week cycles
Adjuvant treatment: Is recommended for a total of 6 months (8 cycles)
In combination with docetaxel: The recommended dose of Capecitabine is 1250 mg/m2 twice daily for 2 weeks followed by a 7-day rest period, combined with docetaxel at 75 mg/m2 as a 1-hour IV infusion every 3 weeks. Capecitabine dosage may need to be individualized to optimize patient management. Capecitabine dosage has to be reduced by 25% in patients with moderate renal impairment.
Example: A person whose body weight is 64 kg and height is 1.64 m has a body surface area of 1.7 m2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg two times daily.
The tablets should be taken in morning and evening as prescribed by doctor. The tablets should be taken within 30 minutes after the end of a meal (breakfast and dinner) and swallowed whole with water. Tablets should not be cut or crushed. Capecitabine should only be prescribed by a doctor experienced in the use of anticancer medicines.
Adjuvant treatment: Is recommended for a total of 6 months (8 cycles)
In combination with docetaxel: The recommended dose of Capecitabine is 1250 mg/m2 twice daily for 2 weeks followed by a 7-day rest period, combined with docetaxel at 75 mg/m2 as a 1-hour IV infusion every 3 weeks. Capecitabine dosage may need to be individualized to optimize patient management. Capecitabine dosage has to be reduced by 25% in patients with moderate renal impairment.
Example: A person whose body weight is 64 kg and height is 1.64 m has a body surface area of 1.7 m2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg two times daily.
The tablets should be taken in morning and evening as prescribed by doctor. The tablets should be taken within 30 minutes after the end of a meal (breakfast and dinner) and swallowed whole with water. Tablets should not be cut or crushed. Capecitabine should only be prescribed by a doctor experienced in the use of anticancer medicines.
Side effectsView
Abdominal pain, Rash, dry or itchy skin, Tiredness, loss of appetite (anorexia), Diarrhea, Vomiting, Nausea, Stomatitis, Hand-and-foot skin-reaction, Fever, Infection, Chest pain, Steven-Johnson syndrome
ContraindicationsView
- Severe Renal Impairment
- Hypersensitivity
- leucopenia, neutropenia or thrombocytopenia
- Severe reactions to fluoropyrimidine therapy
- Complete DPD deficiency
- Pregnant or breast-feeding
PrecautionsView
Coagulopathy: Anticoagulant response should be monitored (e.g. INR) and anticoagulant dose must be adjusted accordingly. Otherwise may result in bleeding, death.
Diarrhea: Capecitabine treatment should be stopped immediately until diarrhea resolves or decreases to grade 1. Standard antidiarrheal treatments recommended. Otherwise may get severe.
Cardiotoxicity: Common in patients with a prior history of coronary artery disease.
Increased Risk of Severe or Fatal Adverse Reactions in Patients with Low or Absent Dihydropyrimidine Dehydrogenase (DPD) Activity: Capecitabine should be withhold or permanently discontinued in patients with evidence of acute early-onset or unusually severe toxicity, which may indicate near complete or total absence of DPD activity.
Dehydration and Renal Failure: Capecitabine treatment should be stopped until dehydration is corrected. Potential risk of acute renal failure secondary to dehydration.
Mucocutaneous and Dermatologic Toxicity: Severe mucocutaneous reactions, Steven-Johnson Syndrome. (SJS) and Toxic Epidermal Necrolysis (TEN), have been reported. Capecitabine should be permanently discontinued in patients who experience a severe mucocutaneous reaction during treatment. Capecitabine may induce hand-and-foot syndrome. Capecitabine treatment should be interrupted until the hand-and-foot syndrome event resolves or decreases in intensity.
Hyperbilirubinemia: Capecitabine treatment should be interrupted immediately until the hyperbilirubinemia resolves or decreases in intensity.
Hematologic: Patients should not be treated with neutrophil counts <1.5x109/L or thrombocyte counts <100x109/L.
Diarrhea: Capecitabine treatment should be stopped immediately until diarrhea resolves or decreases to grade 1. Standard antidiarrheal treatments recommended. Otherwise may get severe.
Cardiotoxicity: Common in patients with a prior history of coronary artery disease.
Increased Risk of Severe or Fatal Adverse Reactions in Patients with Low or Absent Dihydropyrimidine Dehydrogenase (DPD) Activity: Capecitabine should be withhold or permanently discontinued in patients with evidence of acute early-onset or unusually severe toxicity, which may indicate near complete or total absence of DPD activity.
Dehydration and Renal Failure: Capecitabine treatment should be stopped until dehydration is corrected. Potential risk of acute renal failure secondary to dehydration.
Mucocutaneous and Dermatologic Toxicity: Severe mucocutaneous reactions, Steven-Johnson Syndrome. (SJS) and Toxic Epidermal Necrolysis (TEN), have been reported. Capecitabine should be permanently discontinued in patients who experience a severe mucocutaneous reaction during treatment. Capecitabine may induce hand-and-foot syndrome. Capecitabine treatment should be interrupted until the hand-and-foot syndrome event resolves or decreases in intensity.
Hyperbilirubinemia: Capecitabine treatment should be interrupted immediately until the hyperbilirubinemia resolves or decreases in intensity.
Hematologic: Patients should not be treated with neutrophil counts <1.5x109/L or thrombocyte counts <100x109/L.
InteractionsView
- Anticoagulants: Anticoagulant response (INR or prothrombin time) should be monitored frequently in order to adjust the anticoagulant dose as needed.
- Phenytoin: Phenytoin levels should be monitored in patients taking Capecitabine concomitantly with phenytoin. The phenytoin dose may need to be reduced.
- Leucovorin: The concentration of 5-fluorouracil is increased and its toxicity may be enhanced by leucovorin.
- CYP2C9 substrates: Care should be exercised when Capecitabine is co-administered with CYP2C9 substrates.
- Food: Reduced both the rate and extent of absorption of Capecitabine.
Pregnancy & lactationView
Pregnancy category D. Capecitabine can cause fetal harm. Women are advised of the potential risk to the fetus. It is not known whether Capecitabine is excreted in human breast milk.No studies have been conducted to assess the impact of Capecitabine on milk production or its presence in human breast milk. As the potential for harm to the nursing infant is unknown, breast-feeding should be discontinued while receiving treatment with Capecitabine and for 2 weeks after the final dose.
Overdose effectsView
The manifestations of acute overdose include nausea, vomiting, diarrhea, mucositis, gastrointestinal irritation and bleeding, and bone marrow depression. Medical management of overdose should include customary therapeutic and supportive medical interventions aimed at correcting the presenting clinical manifestations and preventing their possible complications.
StorageView
Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.
Xitabin
Capecitabine
Xitabin
Capecitabine
Indications
Carcinoma of the colon or rectum
Indication detailsView
Capecitabine is a nucleoside metabolic inhibitor with antineoplastic activity indicated for:
- Adjuvant Colon Cancer: Patients with Dukes'C colon cancer.
- Metastatic Colorectal Cancer: First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred.
- Metastatic Breast Cancer: In combination with docetaxel after failure of prior anthracycline containing therapy.
- As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen.
Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Capecitabine is a preparation of Capecitabine, an orally-administered chemotherapeutic agent used in the treatment of cancers. Capecitabine is a prodrug, that is enzymatically converted to fluorouracil (antimetabolite) in the tumour, where it inhibits DNA synthesis and slows growth of tumour tissue.
Capecitabine is a prodrug that is selectively tumour-activated to its cytotoxic moiety, fluorouracil, by thymidine phosphorylase, an enzyme found in higher concentrations in many tumours compared to normal tissues or plasma. Fluorouracil is further metabolized to two active metabolites, 5-fluoro-2'-deoxyuridine 5-monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP), within normal and tumour cells. These metabolites cause cell injury by two different mechanisms. First, FdUMP and the folate cofactor, N5-10 methylenetetrahydrofolate, bind to thymidylate synthase (TS) to form a covalently bound ternary complex. This binding inhibits the formation of thymidylate from 2-deoxyuridylate. Thymidylate is the necessary precursor of thymidine triphosphate, which is essential for the synthesis of DNA, therefore a deficiency of this compound can inhibit cell division. Secondly, nuclear transcriptional enzymes can mistakenly incorporate FUTP in place of uridine triphosphate (UTP) during the synthesis of RNA. This metabolic error can interfere with RNA processing and protein synthesis through the production of fraudulent RNA.
Capecitabine is a prodrug that is selectively tumour-activated to its cytotoxic moiety, fluorouracil, by thymidine phosphorylase, an enzyme found in higher concentrations in many tumours compared to normal tissues or plasma. Fluorouracil is further metabolized to two active metabolites, 5-fluoro-2'-deoxyuridine 5-monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP), within normal and tumour cells. These metabolites cause cell injury by two different mechanisms. First, FdUMP and the folate cofactor, N5-10 methylenetetrahydrofolate, bind to thymidylate synthase (TS) to form a covalently bound ternary complex. This binding inhibits the formation of thymidylate from 2-deoxyuridylate. Thymidylate is the necessary precursor of thymidine triphosphate, which is essential for the synthesis of DNA, therefore a deficiency of this compound can inhibit cell division. Secondly, nuclear transcriptional enzymes can mistakenly incorporate FUTP in place of uridine triphosphate (UTP) during the synthesis of RNA. This metabolic error can interfere with RNA processing and protein synthesis through the production of fraudulent RNA.
DosageView
Monotherapy: 1250 mg/m2 twice daily orally for 2 weeks followed by a one-week rest period in 3-week cycles
Adjuvant treatment: Is recommended for a total of 6 months (8 cycles)
In combination with docetaxel: The recommended dose of Capecitabine is 1250 mg/m2 twice daily for 2 weeks followed by a 7-day rest period, combined with docetaxel at 75 mg/m2 as a 1-hour IV infusion every 3 weeks. Capecitabine dosage may need to be individualized to optimize patient management. Capecitabine dosage has to be reduced by 25% in patients with moderate renal impairment.
Example: A person whose body weight is 64 kg and height is 1.64 m has a body surface area of 1.7 m2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg two times daily.
The tablets should be taken in morning and evening as prescribed by doctor. The tablets should be taken within 30 minutes after the end of a meal (breakfast and dinner) and swallowed whole with water. Tablets should not be cut or crushed. Capecitabine should only be prescribed by a doctor experienced in the use of anticancer medicines.
Adjuvant treatment: Is recommended for a total of 6 months (8 cycles)
In combination with docetaxel: The recommended dose of Capecitabine is 1250 mg/m2 twice daily for 2 weeks followed by a 7-day rest period, combined with docetaxel at 75 mg/m2 as a 1-hour IV infusion every 3 weeks. Capecitabine dosage may need to be individualized to optimize patient management. Capecitabine dosage has to be reduced by 25% in patients with moderate renal impairment.
Example: A person whose body weight is 64 kg and height is 1.64 m has a body surface area of 1.7 m2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg two times daily.
The tablets should be taken in morning and evening as prescribed by doctor. The tablets should be taken within 30 minutes after the end of a meal (breakfast and dinner) and swallowed whole with water. Tablets should not be cut or crushed. Capecitabine should only be prescribed by a doctor experienced in the use of anticancer medicines.
Side effectsView
Abdominal pain, Rash, dry or itchy skin, Tiredness, loss of appetite (anorexia), Diarrhea, Vomiting, Nausea, Stomatitis, Hand-and-foot skin-reaction, Fever, Infection, Chest pain, Steven-Johnson syndrome
ContraindicationsView
- Severe Renal Impairment
- Hypersensitivity
- leucopenia, neutropenia or thrombocytopenia
- Severe reactions to fluoropyrimidine therapy
- Complete DPD deficiency
- Pregnant or breast-feeding
PrecautionsView
Coagulopathy: Anticoagulant response should be monitored (e.g. INR) and anticoagulant dose must be adjusted accordingly. Otherwise may result in bleeding, death.
Diarrhea: Capecitabine treatment should be stopped immediately until diarrhea resolves or decreases to grade 1. Standard antidiarrheal treatments recommended. Otherwise may get severe.
Cardiotoxicity: Common in patients with a prior history of coronary artery disease.
Increased Risk of Severe or Fatal Adverse Reactions in Patients with Low or Absent Dihydropyrimidine Dehydrogenase (DPD) Activity: Capecitabine should be withhold or permanently discontinued in patients with evidence of acute early-onset or unusually severe toxicity, which may indicate near complete or total absence of DPD activity.
Dehydration and Renal Failure: Capecitabine treatment should be stopped until dehydration is corrected. Potential risk of acute renal failure secondary to dehydration.
Mucocutaneous and Dermatologic Toxicity: Severe mucocutaneous reactions, Steven-Johnson Syndrome. (SJS) and Toxic Epidermal Necrolysis (TEN), have been reported. Capecitabine should be permanently discontinued in patients who experience a severe mucocutaneous reaction during treatment. Capecitabine may induce hand-and-foot syndrome. Capecitabine treatment should be interrupted until the hand-and-foot syndrome event resolves or decreases in intensity.
Hyperbilirubinemia: Capecitabine treatment should be interrupted immediately until the hyperbilirubinemia resolves or decreases in intensity.
Hematologic: Patients should not be treated with neutrophil counts <1.5x109/L or thrombocyte counts <100x109/L.
Diarrhea: Capecitabine treatment should be stopped immediately until diarrhea resolves or decreases to grade 1. Standard antidiarrheal treatments recommended. Otherwise may get severe.
Cardiotoxicity: Common in patients with a prior history of coronary artery disease.
Increased Risk of Severe or Fatal Adverse Reactions in Patients with Low or Absent Dihydropyrimidine Dehydrogenase (DPD) Activity: Capecitabine should be withhold or permanently discontinued in patients with evidence of acute early-onset or unusually severe toxicity, which may indicate near complete or total absence of DPD activity.
Dehydration and Renal Failure: Capecitabine treatment should be stopped until dehydration is corrected. Potential risk of acute renal failure secondary to dehydration.
Mucocutaneous and Dermatologic Toxicity: Severe mucocutaneous reactions, Steven-Johnson Syndrome. (SJS) and Toxic Epidermal Necrolysis (TEN), have been reported. Capecitabine should be permanently discontinued in patients who experience a severe mucocutaneous reaction during treatment. Capecitabine may induce hand-and-foot syndrome. Capecitabine treatment should be interrupted until the hand-and-foot syndrome event resolves or decreases in intensity.
Hyperbilirubinemia: Capecitabine treatment should be interrupted immediately until the hyperbilirubinemia resolves or decreases in intensity.
Hematologic: Patients should not be treated with neutrophil counts <1.5x109/L or thrombocyte counts <100x109/L.
InteractionsView
- Anticoagulants: Anticoagulant response (INR or prothrombin time) should be monitored frequently in order to adjust the anticoagulant dose as needed.
- Phenytoin: Phenytoin levels should be monitored in patients taking Capecitabine concomitantly with phenytoin. The phenytoin dose may need to be reduced.
- Leucovorin: The concentration of 5-fluorouracil is increased and its toxicity may be enhanced by leucovorin.
- CYP2C9 substrates: Care should be exercised when Capecitabine is co-administered with CYP2C9 substrates.
- Food: Reduced both the rate and extent of absorption of Capecitabine.
Pregnancy & lactationView
Pregnancy category D. Capecitabine can cause fetal harm. Women are advised of the potential risk to the fetus. It is not known whether Capecitabine is excreted in human breast milk.No studies have been conducted to assess the impact of Capecitabine on milk production or its presence in human breast milk. As the potential for harm to the nursing infant is unknown, breast-feeding should be discontinued while receiving treatment with Capecitabine and for 2 weeks after the final dose.
Overdose effectsView
The manifestations of acute overdose include nausea, vomiting, diarrhea, mucositis, gastrointestinal irritation and bleeding, and bone marrow depression. Medical management of overdose should include customary therapeutic and supportive medical interventions aimed at correcting the presenting clinical manifestations and preventing their possible complications.
StorageView
Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.
Xitil
Cefuroxime Axetil
Xitil
Cefuroxime Axetil
Indications
Urinary tract infection
Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
- Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
- Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
- Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
- Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli
- Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
- Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
- Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
- Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
- Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
- Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.
DosageView
Tablet or Suspension-
Adolescents and adults (13 years and older)-- Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
- Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
- Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
- Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
- Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
- Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
- Uncomplicated Gonorrhoea: 1000 mg Single dose
- Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
- MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
- Early Lyme disease: 500 mg b.i.d. for 20 days
- Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
- Acute otitis media: 30 mg/kg/day b.i.d for 10 days
- Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
- Impetigo: 30 mg/kg/day b.i.d for 10 days
Parenteral-
- Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
- Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
- Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
- Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
- Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)- In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).
- Adult: 3 gm IV injection three times daily.
- Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
- Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.
- Adult: 1.5 gm IV injection four times daily.
- Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.
AdministrationView
The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5o C
Side effectsView
Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.
ContraindicationsView
Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.
PrecautionsView
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.
InteractionsView
No potentially hazardous interactions have been reported.
Pregnancy & lactationView
US FDA pregnancy category of Cefuroxime 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. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.
ReconstitutionView
For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.
For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
StorageView
Store in a cool, dry place (below 30o C), away from light & moisture. Keep out of the reach of children.
Xitil
Cefuroxime Axetil
Xitil
Cefuroxime Axetil
Indications
Urinary tract infection
Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
- Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
- Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
- Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
- Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli
- Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
- Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
- Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
- Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
- Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
- Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.
DosageView
Tablet or Suspension-
Adolescents and adults (13 years and older)-- Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
- Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
- Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
- Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
- Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
- Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
- Uncomplicated Gonorrhoea: 1000 mg Single dose
- Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
- MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
- Early Lyme disease: 500 mg b.i.d. for 20 days
- Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
- Acute otitis media: 30 mg/kg/day b.i.d for 10 days
- Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
- Impetigo: 30 mg/kg/day b.i.d for 10 days
Parenteral-
- Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
- Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
- Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
- Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
- Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)- In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).
- Adult: 3 gm IV injection three times daily.
- Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
- Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.
- Adult: 1.5 gm IV injection four times daily.
- Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.
AdministrationView
The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5o C
Side effectsView
Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.
ContraindicationsView
Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.
PrecautionsView
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.
InteractionsView
No potentially hazardous interactions have been reported.
Pregnancy & lactationView
US FDA pregnancy category of Cefuroxime 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. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.
ReconstitutionView
For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.
For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
StorageView
Store in a cool, dry place (below 30o C), away from light & moisture. Keep out of the reach of children.
Xitil
Cefuroxime Axetil
Xitil
Cefuroxime Axetil
Indications
Urinary tract infection
Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
- Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
- Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
- Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
- Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli
- Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
- Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
- Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
- Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
- Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
- Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.
DosageView
Tablet or Suspension-
Adolescents and adults (13 years and older)-- Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
- Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
- Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
- Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
- Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
- Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
- Uncomplicated Gonorrhoea: 1000 mg Single dose
- Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
- MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
- Early Lyme disease: 500 mg b.i.d. for 20 days
- Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
- Acute otitis media: 30 mg/kg/day b.i.d for 10 days
- Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
- Impetigo: 30 mg/kg/day b.i.d for 10 days
Parenteral-
- Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
- Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
- Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
- Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
- Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)- In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).
- Adult: 3 gm IV injection three times daily.
- Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
- Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.
- Adult: 1.5 gm IV injection four times daily.
- Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.
AdministrationView
The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5o C
Side effectsView
Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.
ContraindicationsView
Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.
PrecautionsView
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.
InteractionsView
No potentially hazardous interactions have been reported.
Pregnancy & lactationView
US FDA pregnancy category of Cefuroxime 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. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.
ReconstitutionView
For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.
For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
StorageView
Store in a cool, dry place (below 30o C), away from light & moisture. Keep out of the reach of children.
Xitob
Tobramycin (Ophthalmic)
Xitob
Tobramycin (Ophthalmic)
Indications
Ocular infections
Indication detailsView
Tobramycin is a topical antibiotic indicated in the treatment of external bacterial infections of the eye caused by susceptible organisms. Such as,
Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus spp. of group A beta-hemolytic and some nonhemolytic species.
Gram-negative bacteria: E.coli, Pseudomonas aeruginosa, Enterobacter aerogenes, Klebsiella spp., Proteusmirabillis, Proteus vulgaris, Haemophilus influenzae, Morganella morganii, Acinetobacter calcoaceticus, Providentia, Serratia, Salmonella spp and some strains of Neisseria.
Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus spp. of group A beta-hemolytic and some nonhemolytic species.
Gram-negative bacteria: E.coli, Pseudomonas aeruginosa, Enterobacter aerogenes, Klebsiella spp., Proteusmirabillis, Proteus vulgaris, Haemophilus influenzae, Morganella morganii, Acinetobacter calcoaceticus, Providentia, Serratia, Salmonella spp and some strains of Neisseria.
Therapeutic classView
Ophthalmic antibacterial drugs
PharmacologyView
Like other aminoglycosides, the bactericidal activity of Tobramycin is taken up into sensitive bacterial cells by an active transport process. Within the cell Tobramycin bind to the 30s, and to some extent to the 50s subunits of the bacterial ribosome, inhibiting protein synthesis and generating errors in the transcription of the genetic code. The manner in which cell death is brought about is imperfectly understood, and other mechanisms may contribute, including effects on membrane permeability.
DosageView
Ophthalmic ointment:
- In mild to moderate infection, apply a small amount 2-3 times daily into the conjunctival sac(s).
- In severe cases of infection, apply a small amount 3-4 times daily into the conjunctival sac(s) until improvement is obtained, then reduce the dose gradually.
- In mild to moderate infections: Instill 1or 2 drops into the affected eye(s) every 4 hours.
- In severe infections: Instill 2 drops into the affected eye(s) every hour until improvement is observed.
Side effectsView
The most frequent side effect of Tobramycin ophthalmic solution is localized ocular toxicity, conjunctival erythema, hypersensitivity including lid itching and swelling.
ContraindicationsView
It is contraindicated in patients who are hypersensitive to Tobramycin or any of the ingredients of the preparation.
PrecautionsView
Minor sensitivity may occur to topically applied aminoglycosides in some patients. If a sensitivity reaction occurs, discontinue use. Prolonged use may result in overgrowth of nonsusceptible organisms and fungi.
InteractionsView
Care should be exercised when tobramycin is given to patients receiving other drugs with neuromauscular blocking agents or ototoxic.
Pregnancy & lactationView
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should only be used during pregnancy, if the potential benefits outweigh the possible risk to the fetus. Drug may excreted into human milk. A decision should be made whether to discontinue nursing or to taking the drug.
Overdose effectsView
Sign and symptoms of overdose may be similar to side effects as described above.
StorageView
Protect from light, store in cool (below 25°C) & dry place. Keep out of reach of children. Used within 4 weeks after first opening.
Xiva
Doxophylline
Xiva
Doxophylline
Indications
Severe bronchospasm
Indication detailsView
Doxophylline is used to treat in following indications:
- Bronchial asthma
- Bronchospasm
- Chronic obstructive pulmonary disease (COPD)
- Pulmonary disease with spastic bronchial component.
Therapeutic classView
Bronchodilator, Methyl xanthine derivatives
PharmacologyView
Doxophylline is a novel bronchodilator. It structurally differs from Theophylline due to the presence of a dioxolane group in position 7. Doxophylline selectively inhibits phosphodiesterase 4 thereby relaxes bronchial smooth muscle. However, differently from Theophylline, Doxophylline appears to have decreased affinities toward adenosine A1 and A2 receptors, which may account for the better safety profile of the drug. Doxophylline is reported to inhibit platelet activating factor (PAF) and generation of leukotriene production.
DosageView
Elderly: 200 mg tablet two or three times daily.
Adults: 400 mg tablet two or three times daily or as prescribed by the physician.
Children:
Adults: 400 mg tablet two or three times daily or as prescribed by the physician.
Children:
- >12 years of age: 10 ml syrup or 200 mg tablet two or three times daily.
- 6-12 years of age: 6-9 mg/kg body weight two times daily, i.e. if body weight is 10 kg, 3 ml (60 mg) two times daily or as prescribed by the physician.
Side effectsView
Doxophylline rarely causes serious side effects, however possible side effects are similar for taking excess amount of caffeine. These include: nausea, vomiting, headache, upset stomach and heartburn.
ContraindicationsView
Doxophylline is contraindicated in acute myocardial infarction. It is also contraindicated in patients with hypotension, in lactating women & patients who have shown hypersensitivity to its components.
PrecautionsView
The half-life of xanthine derivatives is influenced by a number of known variables. It may be prolonged in patients with liver disease, in patients with congestive heart failure and in those patients taking certain other drugs like erythromycin, troleandomycin, lincomycin, allopurinol, cimetidine, propanolol and anti-flu vaccine. In these cases, a lower dose of Doxophylline may be needed. Phenytoin, other anticonvulsants and smoking may cause an increase in clearance with a shorter mean half-life. In these cases higher doses of Doxophylline may be needed.
InteractionsView
Doxophylline should not be administered together with other xanthine derivatives. Toxic synergism with ephedrine has been documented for xanthines. Like other xanthines, concomitant therapy with troleandomycin, lincomycin, clindamycin, allopurinol, cimetidine, ranitidine, propranolol and anti-flu vaccine may decrease the hepatic clearance of xanthines causing an increase in blood levels. No evidence of a relationship between Doxophylline serum concentrations and toxic events have been reported.
Pregnancy & lactationView
Animal reproduction studies indicate that, Doxophylline does not cause fetal harm when administered to pregnant animals or can not affect reproduction capacity. However, since there is limited experience in human during pregnancy, xanthines should be given to pregnant women only if clearly needed. Doxophylline is contraindicated in nursing mothers.
Overdose effectsView
In case of overdose severe cardiac arrhythmias and tonic-clonic seizure may occur. These effects may represent the first signs of intoxication. The appearance of side effects may require discontinuation of the treatment which, if necessary, at the physician’s discretion, may be resumed at lower doses after all signs and symptoms of toxicity have subsided.
As there is no specific antidote, in case of overdose a symptomatic treatment of cardiovascular collapse should be instituted.
As there is no specific antidote, in case of overdose a symptomatic treatment of cardiovascular collapse should be instituted.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children. Doxophylline should be used only on prescription of specialist physician.
Xiva
Doxophylline
Xiva
Doxophylline
Indications
Severe bronchospasm
Indication detailsView
Doxophylline is used to treat in following indications:
- Bronchial asthma
- Bronchospasm
- Chronic obstructive pulmonary disease (COPD)
- Pulmonary disease with spastic bronchial component.
Therapeutic classView
Bronchodilator, Methyl xanthine derivatives
PharmacologyView
Doxophylline is a novel bronchodilator. It structurally differs from Theophylline due to the presence of a dioxolane group in position 7. Doxophylline selectively inhibits phosphodiesterase 4 thereby relaxes bronchial smooth muscle. However, differently from Theophylline, Doxophylline appears to have decreased affinities toward adenosine A1 and A2 receptors, which may account for the better safety profile of the drug. Doxophylline is reported to inhibit platelet activating factor (PAF) and generation of leukotriene production.
DosageView
Elderly: 200 mg tablet two or three times daily.
Adults: 400 mg tablet two or three times daily or as prescribed by the physician.
Children:
Adults: 400 mg tablet two or three times daily or as prescribed by the physician.
Children:
- >12 years of age: 10 ml syrup or 200 mg tablet two or three times daily.
- 6-12 years of age: 6-9 mg/kg body weight two times daily, i.e. if body weight is 10 kg, 3 ml (60 mg) two times daily or as prescribed by the physician.
Side effectsView
Doxophylline rarely causes serious side effects, however possible side effects are similar for taking excess amount of caffeine. These include: nausea, vomiting, headache, upset stomach and heartburn.
ContraindicationsView
Doxophylline is contraindicated in acute myocardial infarction. It is also contraindicated in patients with hypotension, in lactating women & patients who have shown hypersensitivity to its components.
PrecautionsView
The half-life of xanthine derivatives is influenced by a number of known variables. It may be prolonged in patients with liver disease, in patients with congestive heart failure and in those patients taking certain other drugs like erythromycin, troleandomycin, lincomycin, allopurinol, cimetidine, propanolol and anti-flu vaccine. In these cases, a lower dose of Doxophylline may be needed. Phenytoin, other anticonvulsants and smoking may cause an increase in clearance with a shorter mean half-life. In these cases higher doses of Doxophylline may be needed.
InteractionsView
Doxophylline should not be administered together with other xanthine derivatives. Toxic synergism with ephedrine has been documented for xanthines. Like other xanthines, concomitant therapy with troleandomycin, lincomycin, clindamycin, allopurinol, cimetidine, ranitidine, propranolol and anti-flu vaccine may decrease the hepatic clearance of xanthines causing an increase in blood levels. No evidence of a relationship between Doxophylline serum concentrations and toxic events have been reported.
Pregnancy & lactationView
Animal reproduction studies indicate that, Doxophylline does not cause fetal harm when administered to pregnant animals or can not affect reproduction capacity. However, since there is limited experience in human during pregnancy, xanthines should be given to pregnant women only if clearly needed. Doxophylline is contraindicated in nursing mothers.
Overdose effectsView
In case of overdose severe cardiac arrhythmias and tonic-clonic seizure may occur. These effects may represent the first signs of intoxication. The appearance of side effects may require discontinuation of the treatment which, if necessary, at the physician’s discretion, may be resumed at lower doses after all signs and symptoms of toxicity have subsided.
As there is no specific antidote, in case of overdose a symptomatic treatment of cardiovascular collapse should be instituted.
As there is no specific antidote, in case of overdose a symptomatic treatment of cardiovascular collapse should be instituted.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children. Doxophylline should be used only on prescription of specialist physician.
Xmec
Meclizine + Pyridoxine
Xmec
Meclizine + Pyridoxine
Indications
Pregnancy-associated nausea and vomiting
Indication detailsView
Prevention and treatment of nausea, vomiting, dizziness, motion sickness, radiation sickness and vertigo associated with diseases of the vestibular system (e.g. Meniere's syndrome, labyrinthitis and other vestibular disturbances).
Therapeutic classView
Anti-emetic drugs
PharmacologyView
Meclizine is a piperazine-derivative antihistamine that is used as an antiemetic. It has antiemetic, anticholinergic and antihistaminic properties. It reduces the sensitivity of the labyrinthine apparatus. The action may be mediated through nerve pathways to the vomiting center (VC) from the chemoreceptor trigger zone (CTZ), peripheral nerve pathways, the VC, or other CNS centers. Pyridoxine is vitamin B-6. It has been added to enhance the anti-emetic effects & as a dietary suppliment.
DosageView
Adult and Children 12 years of age & over:
- Nausea and vomiting: 25-50 mg daily or as directed by a physician.
- Motion sickness: Take an initial dose of 25-50 mg, 1 hour prior to travel. May repeat the dose every 24 hours for the duration of the journey.
- Radiation sickness: 50 mg administered 2-12 hours prior to radiation treatment.
- Vertigo: 25-100 mg daily in divided doses.
- Prevention of nausea and vomiting associated with emergency contraceptive pill (ECP): 25-50 mg, 1 hour before first ECP dose; repeat if needed in 24 hours.
Side effectsView
Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.
ContraindicationsView
Meclizine Hydrochloride and Pyridoxine Hydrochloride is contraindicated in patients who are hypersensitive to these ingredients.
PrecautionsView
Patients should be warned that Meclizine Hydrochloride may impair their ability to perform hazardous activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle). Patients should avoid alcoholic beverages while taking this drug. Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma or enlargement of the prostate gland.
InteractionsView
The CNS depressant effects of Meclizine can be potentiated by concurrent use of Ethanol or other CNS depressant agents such as Benzodiazepines, Barbiturates, Tricyclic antidepressants, opiate agonists, skeletal muscle relaxants and antihistamines. Concurrent use of other anticholinergics can potentiate the anticholinergic effects of Meclizine. Meclizine can increase the absorption of digoxin by decreasing gastrointestinal motility.
Pregnancy & lactationView
Pregnancy Category B. Large-scale human studies have not demonstrated adverse fetal effects. It has been suggested that based on available data, Meclizine presents the lowest risk of teratogenicity and is the drug of first choice in treating nausea and vomiting during pregnancy. Safety for use in the nursing mother has not been established.
Overdose effectsView
Symptoms: Extreme excitability, seizures, drowsiness and hallucinations.
Treatment: Appropriate supportive and symptomatic treatment. Consider dialysis
Treatment: Appropriate supportive and symptomatic treatment. Consider dialysis
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Xofast
Fexofenadine Hydrochloride
Xofast
Fexofenadine Hydrochloride
Indications
Urticaria
Indication detailsView
Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.
DosageView
Seasonal Allergic Rhinitis-
Adults and children 12 years and older:
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 30 mg or 5 ml twice daily
- In case of impaired renal function: 30 mg or 5 ml once daily
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
- In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily
- Suspension: 30 mg or 5 ml (1 tsp) twice daily
- In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily
Side effectsView
Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.
ContraindicationsView
Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.
PrecautionsView
Caution should be exercised in elderly patient and patient with decreased renal function.
InteractionsView
Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.
Pregnancy & lactationView
US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Overdose effectsView
In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xofast
Fexofenadine Hydrochloride
Xofast
Fexofenadine Hydrochloride
Indications
Urticaria
Indication detailsView
Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.
DosageView
Seasonal Allergic Rhinitis-
Adults and children 12 years and older:
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 30 mg or 5 ml twice daily
- In case of impaired renal function: 30 mg or 5 ml once daily
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
- In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily
- Suspension: 30 mg or 5 ml (1 tsp) twice daily
- In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily
Side effectsView
Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.
ContraindicationsView
Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.
PrecautionsView
Caution should be exercised in elderly patient and patient with decreased renal function.
InteractionsView
Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.
Pregnancy & lactationView
US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Overdose effectsView
In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xofedin
Fexofenadine Hydrochloride
Xofedin
Fexofenadine Hydrochloride
Indications
Urticaria
Indication detailsView
Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.
DosageView
Seasonal Allergic Rhinitis-
Adults and children 12 years and older:
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 30 mg or 5 ml twice daily
- In case of impaired renal function: 30 mg or 5 ml once daily
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
- In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily
- Suspension: 30 mg or 5 ml (1 tsp) twice daily
- In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily
Side effectsView
Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.
ContraindicationsView
Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.
PrecautionsView
Caution should be exercised in elderly patient and patient with decreased renal function.
InteractionsView
Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.
Pregnancy & lactationView
US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Overdose effectsView
In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xofedin
Fexofenadine Hydrochloride
Xofedin
Fexofenadine Hydrochloride
Indications
Urticaria
Indication detailsView
Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.
DosageView
Seasonal Allergic Rhinitis-
Adults and children 12 years and older:
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 30 mg or 5 ml twice daily
- In case of impaired renal function: 30 mg or 5 ml once daily
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
- In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily
- Suspension: 30 mg or 5 ml (1 tsp) twice daily
- In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily
Side effectsView
Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.
ContraindicationsView
Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.
PrecautionsView
Caution should be exercised in elderly patient and patient with decreased renal function.
InteractionsView
Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.
Pregnancy & lactationView
US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Overdose effectsView
In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xofena
Fexofenadine Hydrochloride
Xofena
Fexofenadine Hydrochloride
Indications
Urticaria
Indication detailsView
Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.
DosageView
Seasonal Allergic Rhinitis-
Adults and children 12 years and older:
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 30 mg or 5 ml twice daily
- In case of impaired renal function: 30 mg or 5 ml once daily
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
- In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily
- Suspension: 30 mg or 5 ml (1 tsp) twice daily
- In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily
Side effectsView
Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.
ContraindicationsView
Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.
PrecautionsView
Caution should be exercised in elderly patient and patient with decreased renal function.
InteractionsView
Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.
Pregnancy & lactationView
US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Overdose effectsView
In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xofena
Fexofenadine Hydrochloride
Xofena
Fexofenadine Hydrochloride
Indications
Urticaria
Indication detailsView
Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.
DosageView
Seasonal Allergic Rhinitis-
Adults and children 12 years and older:
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 30 mg or 5 ml twice daily
- In case of impaired renal function: 30 mg or 5 ml once daily
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
- In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily
- Suspension: 30 mg or 5 ml (1 tsp) twice daily
- In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily
Side effectsView
Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.
ContraindicationsView
Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.
PrecautionsView
Caution should be exercised in elderly patient and patient with decreased renal function.
InteractionsView
Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.
Pregnancy & lactationView
US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Overdose effectsView
In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xofena
Fexofenadine Hydrochloride
Xofena
Fexofenadine Hydrochloride
Indications
Urticaria
Indication detailsView
Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.
DosageView
Seasonal Allergic Rhinitis-
Adults and children 12 years and older:
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 30 mg or 5 ml twice daily
- In case of impaired renal function: 30 mg or 5 ml once daily
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
- In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily
- Suspension: 30 mg or 5 ml (1 tsp) twice daily
- In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily
Side effectsView
Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.
ContraindicationsView
Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.
PrecautionsView
Caution should be exercised in elderly patient and patient with decreased renal function.
InteractionsView
Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.
Pregnancy & lactationView
US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Overdose effectsView
In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xoferon
Iron Sucrose Injection [Elemental Iron]
Xoferon
Iron Sucrose Injection [Elemental Iron]
Indications
Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin
Indication detailsView
This is indicated for the treatment of Iron deficiency in the following indications:
- Where there is a clinical need for a rapid Iron supply
- In patients who can not tolerate oral Iron therapy or who are non-compliant
- In active inflammatory bowel disease where oral Iron preparations are ineffective
- Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving an erythropoietin
- Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin
- Hemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietin
- Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin
- It is also indicated in the treatment of Iron deficiency anaemia in patients undergoing surgical procedures, patients donating blood, postpartum patients.
Therapeutic classView
Parenteral Iron Preparations
PharmacologyView
The therapeutic class of Iron Sucrose is haematinic. Iron Sucrose Injection USP is a brown, sterile, aqueous, complex of Polynuclear Iron (III) Hydroxide in Sucrose for Intravenous use. The drug product contains approximately 30% Sucrose w/v (300 mg/ml) and has a pH of 10.5-11.1. Following intravenous administration, Iron Sucrose Injection is dissociated into Iron and Sucrose by the reticuloendothelial system, and Iron is transferred from the blood to a pool of Iron in the liver and bone marrow. Ferritin, an Iron storage protein, binds and sequesters Iron in a nontoxic form, from which Iron is easily available. Iron binds to plasma transferrin, which carries Iron within the plasma and the extracellular fluid to supply the tissues. The transferrin receptor, located in the cell, and the transferrin-receptor complex is returned to the cell membrane. Transferrin without Iron (apotransferrin) is then released to the plasma. The intracellular Iron becomes (mostly) haemoglobin in circulating red blood cells (RBCs). Transferrin synthesis is increased and ferritin production reduced in Iron deficiency. The converse is true when Iron is plentiful. Its elimination halflife is 6 h, total clearance is 1.2 L/h, non-steady state apparent volume of distribution is 10.0 L and steady state apparent volume of distribution is 7.9 L. In Iron Sucrose, its Iron component appears to distribute mainly in blood and to some extent in extravascular fluid. A significant amount of the administered Iron distributes in the liver, spleen and bone marrow and that the bone marrow is an Iron trapping compartment and not a reversible volume distribution. The sucrose component is eliminated mainly through urinary excretion.
DosageView
Adults and Elderly: 5-10 ml Iron Sucrose Injection (100-200 mg Iron) once to three times a week depending on the hemoglobin level.
Children: There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level.
Children: There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level.
AdministrationView
Intravenous injection: Iron Sucrose Injection can also be administered undiluted by slow intravenous injection at the (normal) recommended rate of 1 ml Iron Sucrose Injection (20 mg Iron) per minute [5 ml Iron Sucrose Injection (100 mg Iron) in 2 to 5 minutes]. A maximum of 10 ml Iron Sucrose Injection (200 mg Iron) can be injected per injection. Before administration of the therapeutic dose in a new patient, a test dose of 1 ml Iron Sucrose Injection (20 mg Iron) in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg Iron/kg) in children with a body weight less than 14 kg should be injected over 1 to 2 minutes. If no adverse reactions occur within a waiting period of 15 minutes, the remaining portion of the injection can be administered at recommended speed. After an injection the arm of the patient should be extended.
Infusion: Iron Sucrose Injection should preferably be administered by drip infusion (in order to reduce the risk of hypotensive episodes and paravenous injection) in a dilution of 1 ml Iron Sucrose Injection (20 mg Iron) in max. 20 ml 0.9% w/v Sodium Chloride [5 ml (100 mg Iron) in max. 100 ml 0.9% w/v NaCI etc. up to 25 ml (500 mg Iron) in max. 500 ml 0.9% w/v NaCI]. Dilution must take place immediately prior to infusion and the solution should be administered as follows: 100 mg Iron in at least 15 minutes; 200 mg Iron in at least 30 minutes; 400 mg Iron In at least 1.5 hours, and 500 mg Iron in at least 3.5 hours. Further of the maximum tolerated single dose of 7 mg Iron/kg body weight, an Infusion time of at least 3.5 hours has to be respected, independently of the total dose.
Before administration of the therapeutic dose in a new patient the first 20 mg Iron in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg lron/kg) in children with a body weight less than 14 kg should be infused over 15 minutes as a test dose. If no adverse reactions occur, the remaining portion of the infusion can be administered at recommended speed.
Infusion: Iron Sucrose Injection should preferably be administered by drip infusion (in order to reduce the risk of hypotensive episodes and paravenous injection) in a dilution of 1 ml Iron Sucrose Injection (20 mg Iron) in max. 20 ml 0.9% w/v Sodium Chloride [5 ml (100 mg Iron) in max. 100 ml 0.9% w/v NaCI etc. up to 25 ml (500 mg Iron) in max. 500 ml 0.9% w/v NaCI]. Dilution must take place immediately prior to infusion and the solution should be administered as follows: 100 mg Iron in at least 15 minutes; 200 mg Iron in at least 30 minutes; 400 mg Iron In at least 1.5 hours, and 500 mg Iron in at least 3.5 hours. Further of the maximum tolerated single dose of 7 mg Iron/kg body weight, an Infusion time of at least 3.5 hours has to be respected, independently of the total dose.
Before administration of the therapeutic dose in a new patient the first 20 mg Iron in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg lron/kg) in children with a body weight less than 14 kg should be infused over 15 minutes as a test dose. If no adverse reactions occur, the remaining portion of the infusion can be administered at recommended speed.
Side effectsView
- Adverse reactions, whether or not related to Iron Sucrose injection are as follows: hypotension, cramps/leg cramps, nausea, headache, vomiting, and diarrhea. Some of these symptoms may be seen in patients with chronic renal failure or on hemodialysis not receiving intravenous iron.
- Body as a Whole: headache, fever, pain, asthenia, unwell, malaise, accidental injury. Cardiovascular Disorders
- General: hypotension, chest pain, hypertension, hypervolemia.
- Gastrointestinal Disorders: nausea, vomiting, abdominal pain, elevated liver enzymes.
- Central and Peripheral Nervous System: dizziness.
- Musculoskeletal System: cramps/leg cramps, musculoskeletal pain.
- Respiratory System: dyspnea pneumonia, cough.
- Skin and appendages: pruritus, application site reaction.
- Hypersensitivity reactions: In safety studies, several patients experienced mild or moderate hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. Anaphylactoid reactions including patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with Iron Sucrose administration can occur. So, patients should be given a small test dose initially.
ContraindicationsView
The use of Iron Sucrose is contraindicated in patients with evidence of Iron overload, in patients with known hypersensitivity to Iron Sucrose or any of its inactive components, and in patients with anaemia not caused by Iron deficiency. It is also contraindicated in patients with history of allergic disorders including asthma, eczema and anaphylaxis, liver disease and infections.
PrecautionsView
General: Because body Iron excretion is limited and excess tissue Iron can be hazardous, caution should be exercised to withhold Iron administration in the presence of evidence of tissue Iron overload. Patients receiving Iron Sucrose require periodic monitoring of hematologic and haematinic parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Iron therapy should be withheld in patients with evidence of Iron overload. Transferrin saturation values increase rapidly after IV administration of Iron Sucrose; thus, serum Iron values may be reliably obtained 48 hours after IV dosing.
Hypersensitivity Reactions: Serious hypersensitivity reactions have been rarely reported in patients receiving Iron Sucrose. Several cases of mild or moderate hypersensitivity reactions were observed in these studies.
Hypotension: Hypotension has been reported frequently in hemodialysis patients receiving intravenous Iron. Hypotension following administration of Iron Sucrose may be related to rate of administration and total dose administered. Caution should be taken to administer Iron Sucrose according to recommended guidelines.
Hypersensitivity Reactions: Serious hypersensitivity reactions have been rarely reported in patients receiving Iron Sucrose. Several cases of mild or moderate hypersensitivity reactions were observed in these studies.
Hypotension: Hypotension has been reported frequently in hemodialysis patients receiving intravenous Iron. Hypotension following administration of Iron Sucrose may be related to rate of administration and total dose administered. Caution should be taken to administer Iron Sucrose according to recommended guidelines.
InteractionsView
Drug-drug interactions involving Iron Sucrose have not been studied. Iron Sucrose Injection should not be administered concomitantly with oral iron preparations since the absorption of oral Iron is reduced. Even oral Iron therapy should not be given until 5 days after last injection.
Pregnancy & lactationView
Pregnancy Category-B. No adequate and well controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Iron Sucrose is administered to a nursing woman.
Pediatric usageView
Pediatric Use: Safety and effectiveness of Iron Sucrose in pediatric patients have not been established.
Geriatric Use: No overall differences in safety were observed between the elder subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Injection into dialyser: Iron Sucrose Injection may be administered directly into the venous limb of the dialyser under the same conditions as for intravenous injection.
Hemodialysis Dependent-Chronic Kidney Disease Patients (HDD-CKD): Iron Sucrose Injection may be administered undiluted as a 100 mg slow intravenous injection over 2 to 5 minutes or as an infusion of 100 mg, diluted in a maximum of 100 ml of 0.9% NaCI over a period of at least 15 minutes per consecutive hemodialysis session for a total cumulative dose of 1,000 mg.
Non-Dialysis Dependent-Chronic Kidney Disease Patient (NDD-CKD): Iron Sucrose Injection is administered as a total cumulative dose 1000 mg over a 14 day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions within the 14 day period.
Geriatric Use: No overall differences in safety were observed between the elder subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Injection into dialyser: Iron Sucrose Injection may be administered directly into the venous limb of the dialyser under the same conditions as for intravenous injection.
Hemodialysis Dependent-Chronic Kidney Disease Patients (HDD-CKD): Iron Sucrose Injection may be administered undiluted as a 100 mg slow intravenous injection over 2 to 5 minutes or as an infusion of 100 mg, diluted in a maximum of 100 ml of 0.9% NaCI over a period of at least 15 minutes per consecutive hemodialysis session for a total cumulative dose of 1,000 mg.
Non-Dialysis Dependent-Chronic Kidney Disease Patient (NDD-CKD): Iron Sucrose Injection is administered as a total cumulative dose 1000 mg over a 14 day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions within the 14 day period.
Overdose effectsView
Dosages of Iron Sucrose Injection in excess of Iron needs may lead to accumulation of Iron in storage sites leading to hemosiderosis. Periodic monitoring of Iron parameters such as serum ferritin and transferrin saturation may assist in recognizing Iron accumulation. Iron Sucrose should not be administered to patients with Iron overload and should be discontinued when serum ferritin levels equal or exceed established guidelines. Particular caution should be exercised to avoid Iron overload where anaemia unresponsive to treatment has been incorrectly diagnosed as Iron deficiency anaemia. Symptoms associated with overdosage or infusing Iron Sucrose too rapidly included hypotension, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema. and cardiovascular collapse. Most symptoms have been successfully treated with IV fluids, hydrocortisone, and/or antihistamines. Infusing the solution as recommended or at a slower rate may also alleviate symptoms.
StorageView
Store in a cool (15°C- 30°C) & dry place, protected from light. Keep out of the reach of children. Do not freeze.