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Cykin
Palbociclib
Cykin
Palbociclib
Indications
Endocrine Disorders
Indication detailsView
Palbociclib is a kinase inhibitor indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
- An aromatase inhibitor as initial endocrine-based therapy in postmenopausal women; or
- Fulvestrant in women with disease progression following endocrine therapy.
PharmacologyView
Palbociclib is an inhibitor of Cyclin-dependent kinases (CDK) 4 and 6. cyclin D1 and CDK4/6 are downstream of signaling pathways that lead to cellular proliferation. Palbociclib reduced cellular proliferation of Estrogen receptor (ER)-positive breast cancer cell lines by blocking progression of the cell from G1 into s phase of the cell cycle. Treatment of breast cancer cell lines with the combination of Palbociclib and antiestrogens leads to decreased retinoblastoma (RB) protein phosphorylation resulting in reduced E2F expression and signaling, and increased growth arrest compared to treatment with each drug alone. Treatment of ER-positive breast cancer cell lines with the combination of Palbociclib and antiestrogens led to increased cell senescence compared to each drug alone, which was sustained for up to 6 days following Palbociclib removal and was greater if antiestrogen treatment was continued. In vivo studies using a patient-derived ER-positive breast cancer xenograft model demonstrated that the combination of Palbociclib and letrozole increased the inhibition of RB phosphorylation, downstream signaling, and tumor growth compared to each drug alone.
DosageView
The recommended dose of Palbociclib is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbociclib should be taken with food. Patients should be encouraged to take their dose of Palbociclib at approximately the same time each day. For men treated with combination Palbociclib plus aromatase inhibitor therapy, consider treatment with an LHRH agonist according to current clinical practice standards.
Recommended Dose Modification for Adverse Reactions:
Use in Children: Palbociclib is not indicated for use in children.
Recommended Dose Modification for Adverse Reactions:
- Recommended Starting Dose: 125 mg/day
- First Dose Reduction: 100 mg/day
- Second Dose Reduction: 75 mg/day
Use in Children: Palbociclib is not indicated for use in children.
Side effectsView
Common side effects of Palbociclib include: WBC decreased, Neutrophils decreased, Neutropenia, Platelets decreased, infections, AST increased, ALT increased, Leukopenia, Fatigue, Nausea, Hair loss, Inflammation of the mouth and lips, Diarrhea, Anemia, Rash, Weakness/lethargy, Vomiting, Thrombocytopenia, Dry skin, Fever.
PrecautionsView
Neutropenia: Neutropenia was the most frequently reported adverse reaction. Monitor complete blood counts prior to starting Palbociclib therapy and at the beginning of each cycle, as well as on day 15 of the first 2 cycles, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop grade 3 or 4 neutropenia. Febrile neutropenia has been reported in 1.8% of patients exposed to Palbociclib. One death due to neutropenic sepsis was observed. Physicians should inform patients to promptly report any episodes of fever.
Embryo-Fetal Toxicity: Palbociclib can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Palbociclib and for at least 3 weeks after the last dose.
Embryo-Fetal Toxicity: Palbociclib can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Palbociclib and for at least 3 weeks after the last dose.
InteractionsView
Palbociclib is primarily metabolized by CYP3A and Sulfotransferase (SULT) enzyme SULT2A1. Palbociclib is a
time-dependent inhibitor of CYP3A.
Agents That May Increase Palbociclib Plasma Concentrations: Effect of CYP3A-Inhibitors: Coadministration of a strong CYP3A inhibitor (Itraconazole) increased the plasma exposure of Palbociclib in patients by 87%. Avoid concomitant use of strong CYP3A inhibitors (e.g., Clarithromycin, Indinavir, Itraconazole, Ketoconazole, Lopinavir/Ritonavir, Nefazodone, Nelfinavir, Posaconazole, Ritonavir, Saquinavir, Telaprevir, Telithromycin, And Voriconazole). Avoid grapefruit or grapefruit juice during Palbociclib treatment. If coadministration of Palbociclib with a strong CYP3A inhibitor cannot be avoided, reduce the dose of Palbociclib.
Agents That May Decrease Palbociclib Plasma Concentrations: Effect of CYP3A Inducers: Coadministration of a strong CYP3A Inducer (Rifampin) decreased the plasma exposure of Palbociclib in healthy subjects by 85%. Avoid concomitant use of strong CYP3A inducers (E.G., Phenytoin, Rifampin, Carbamazepine, Enzalutamide, and St John’s Wort).
Drugs That May Have Their Plasma Concentrations Altered By Palbociclib: Coadministration of Midazolam with multiple doses of Palbociclib increased the Midazolam plasma exposure by 61%, in patients, compared to administration of Midazolam alone. The dose of the sensitive CYP3A substrate with a narrow therapeutic index (e.g., Alfentanil, Cyclosporine, Dihydroergotamine, Ergotamine, Everolimus, Fentanyl, Pimozide, Quinidine, Sirolimus, And Tacrolimus) may need to be reduced, as Palbociclib may increase its exposure.
time-dependent inhibitor of CYP3A.
Agents That May Increase Palbociclib Plasma Concentrations: Effect of CYP3A-Inhibitors: Coadministration of a strong CYP3A inhibitor (Itraconazole) increased the plasma exposure of Palbociclib in patients by 87%. Avoid concomitant use of strong CYP3A inhibitors (e.g., Clarithromycin, Indinavir, Itraconazole, Ketoconazole, Lopinavir/Ritonavir, Nefazodone, Nelfinavir, Posaconazole, Ritonavir, Saquinavir, Telaprevir, Telithromycin, And Voriconazole). Avoid grapefruit or grapefruit juice during Palbociclib treatment. If coadministration of Palbociclib with a strong CYP3A inhibitor cannot be avoided, reduce the dose of Palbociclib.
Agents That May Decrease Palbociclib Plasma Concentrations: Effect of CYP3A Inducers: Coadministration of a strong CYP3A Inducer (Rifampin) decreased the plasma exposure of Palbociclib in healthy subjects by 85%. Avoid concomitant use of strong CYP3A inducers (E.G., Phenytoin, Rifampin, Carbamazepine, Enzalutamide, and St John’s Wort).
Drugs That May Have Their Plasma Concentrations Altered By Palbociclib: Coadministration of Midazolam with multiple doses of Palbociclib increased the Midazolam plasma exposure by 61%, in patients, compared to administration of Midazolam alone. The dose of the sensitive CYP3A substrate with a narrow therapeutic index (e.g., Alfentanil, Cyclosporine, Dihydroergotamine, Ergotamine, Everolimus, Fentanyl, Pimozide, Quinidine, Sirolimus, And Tacrolimus) may need to be reduced, as Palbociclib may increase its exposure.
Pregnancy & lactationView
Palbociclib can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.
Overdose effectsView
There is no known antidote for Palbociclib. The treatment of overdose of Palbociclib should consist of general supportive measures.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Cylac
Salicylic Acid + Lactic Acid
Cylac
Salicylic Acid + Lactic Acid
Indications
Warts
Indication detailsView
This is a topical solution indicated in the treatment of warts, corns and calluses.
Information For Patients
Information For Patients
- Warts: A wart is a viral infection of the surface layers of the skin. The incubation period varies from a few weeks to several months. Warts can spread by direct contact with a wart to damaged skin.
- Corns: A corn is a small, hardened area of skin which often looks yellow compared to the surrounding skin. It is typically round or cone-shaped, pointing down into the skin. Corns most often form on the feet and sometimes on the hands and are caused by constant or repeated friction or pressure.
- Calluses: A callus is rough, thickened skin spread over a wide area. Like a corn, it is caused by constant or repeated friction or pressure, but unlike corns, calluses are flat and have normal skin markings.
Therapeutic classView
Combined preparations
PharmacologyView
Salicylic acid is a widely used and effective keratolytic, it produces desquamation and destruction of the epithelium by solubilising the intercellular cement of the Stratum Corneum. Lactic acid affects the keratinisation process, reducing hyperkeratosis and is also caustic, leading to the destruction of hyperkeratotic tissue. Collodion is derived from cellulose in a base containing ethanol and ether. It allows easy and accurate application of the product and dries to leave a film which hydrates the tissue and facilitates penetration of the active ingredients.
DosageView
Unscrew bottle cap and with the help of brush applicator, apply to the affected areas. ‘Before starting to use this topical solution, unscrew the fitted cap, discard it. Carefully remove the plug away from your body to avoid splashing into eyes/ face and discard it, replace with the brush applicator cap provided in
the sealed polybag given in the carton. This topical solution should be applied to the affected areas once daily, according to the following instructions:
the sealed polybag given in the carton. This topical solution should be applied to the affected areas once daily, according to the following instructions:
- Soak affected site in hot water for five minutes.
- Rub surface carefully with pumice stone or emeryboard to remove any hard skin. Dry with your own towel.
- Apply this topical solution using the brush applicator supplied, taking care to avoid contact with normal skin.
- Allow to dry thoroughly and cover with plaster if lesion is large or on the foot to help penetration of active ingredients.
- Continue treatment once daily until the lesion is completely cleared and the ridge lines of the skin have been restored or when the corn can be removed.
- The usual treatment period is 6 to 12 weeks.
Side effectsView
Stinging, burning, or irritation of the skin,Itching, prolonged use over a large skin area may cause salicylate toxicity, ringing sound in the ears (tinnitus), Diarrhoea, Vomiting.
ContraindicationsView
Not for prolonged use in high concentrations and on large areas of the body. Impaired peripheral circulation or diabetes. Avoid broken skin, mouth, eyes, mucous membranes and anogenital region.
PrecautionsView
This preparation is formulated for the controlled corrosion of keratin and thus care should be taken to apply the product to the affected area only. Do not use on the face or anogenital regions or if you are diabetic or have impaired circulation. Do not use on moles, birthmarks or unusual skin growths. Do not treat warts over large areas at one time, or use on infants and very young children unless on medical advice. For External Use Only
InteractionsView
There are no known drug interactions and none well documented.
Pregnancy & lactationView
Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
Overdose effectsView
Excessive topical use may result in burning, particularly of normal skin. Following excessive topical use, apply emollients as required. Following ingestion, administer copious quantities of water and antacids as required. Ingestion may cause nausea, vomiting and abdominal pain.
StorageView
In view of its high inflammability, it is recommended that Salicylic Acid & Lactic Acid be stored in a cool place not exceeding 25°C. Keep away from naked flame. Keep out of reach of children. Since this topical solution is volatile, close the bottle tightly after each use.
Cynocort
Triamcinolone Acetonide (Injection)
Cynocort
Triamcinolone Acetonide (Injection)
Indications
Severe erythema multiforme (Stevens-Johnson syndrome)
Indication detailsView
Post-traumatic osteoarthritis, synovitis of osteoarthritis, rheumatoid arthritis, acute and sub-acute bursitis, epicondylitis, acute non-specific tenosynovitis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe psoriasis, bronchial asthma, contact dermatitis, atopic dermatitis, seasonal or perennial allergic rhinitis.
Therapeutic classView
Corticosteroid, Glucocorticoids, Triamcinolone & Combined preparations
PharmacologyView
The antiinflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition of arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. Firstly, however, these glucocorticoids bind to the glucocorticoid receptors which translocate into the nucleus and bind DNA (GRE) and change genetic expression both positively and negatively. The immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding.
DosageView
Adults and children over 12 years of age: Initial dose is 60 mg. Dosage is usually adjusted within the range of 40 to 80 mg. For local areas, dose for adults is up to 10 mg for smaller areas and up to 40 mg for larger areas.
Children 6 to 12 years: Initial dose is 40 mg
Children 6 to 12 years: Initial dose is 40 mg
Side effectsView
Cushingoid syndrome, weakness, bruising or purpura, aggravation of infections, peptic ulcer, activation of latent or aggravation of existing diabetes, altered menstrual cycle, hirsutism.
ContraindicationsView
Triamcinolone Acetonide injection is contraindicated in patients with a sensitivity to the active or inactive ingredients.
PrecautionsView
Triamcinolone Acetonide injection should be used cautiously in patients with ocular herpes simplex, nonspecific ulcerative colitis, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, Cushing's syndrome, diabetes mellitus, congestive heart failure, chronic nephritis.
InteractionsView
Aminoglutethimide: Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.
Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents (ie, amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.
Antibiotics: Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance.
Anticholinesterases: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.
Anticoagulants, oral: Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.
Antidiabetics: Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
Antitubercular drugs: Serum concentrations of isoniazid may be decreased.
Cholestyramine: Cholestyramine may increase the clearance of corticosteroids.
Cyclosporine: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.
Digitalis glycosides: Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
Estrogens, including oral contraceptives: Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.
Hepatic enzyme inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin): Drugs which induce hepatic microsomal drug metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.
Ketoconazole: Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects.
Nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant use of aspirin (or other nonsteroidal anti-inflammatory drugs) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.
Skin tests: Corticosteroids may suppress reactions to skin tests.
Vaccines: Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible.
Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents (ie, amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.
Antibiotics: Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance.
Anticholinesterases: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.
Anticoagulants, oral: Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.
Antidiabetics: Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
Antitubercular drugs: Serum concentrations of isoniazid may be decreased.
Cholestyramine: Cholestyramine may increase the clearance of corticosteroids.
Cyclosporine: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.
Digitalis glycosides: Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
Estrogens, including oral contraceptives: Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.
Hepatic enzyme inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin): Drugs which induce hepatic microsomal drug metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.
Ketoconazole: Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects.
Nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant use of aspirin (or other nonsteroidal anti-inflammatory drugs) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.
Skin tests: Corticosteroids may suppress reactions to skin tests.
Vaccines: Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible.
Pregnancy & lactationView
Triamcinolone Acetonide injection should be used during pregnancy, nursing mothers if the possible benefits of the medication justify the potential hazards to the fetus or nursing infant.
Pediatric usageView
Use in the elderly: The common adverse effects of systemic corticosteroids such as osteoporosis or hypertension may be associated with more serious consequences in old age. Close clinical supervision is recommended.
Use in children: As corticosteroids can suppress growth, the development of infants and children on prolonged corticosteroid therapy should be carefully observed. Caution should be taken in the event of exposure to chicken pox, measles or other communicable diseases. Children should not be vaccinated or immunized while on corticosteroid therapy. Corticosteroids may also affect endogenous steroid production.
Use in children: As corticosteroids can suppress growth, the development of infants and children on prolonged corticosteroid therapy should be carefully observed. Caution should be taken in the event of exposure to chicken pox, measles or other communicable diseases. Children should not be vaccinated or immunized while on corticosteroid therapy. Corticosteroids may also affect endogenous steroid production.
Overdose effectsView
Treatment of acute overdosage is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.
StorageView
Store at controlled room temperature, 20-25°C, avoid freezing and protect from light.
Cynomin
Cyanocobalamin
Cynomin
Cyanocobalamin
Indications
Vitamin B12 deficiency
Indication detailsView
This preparation is indicated in Pernicious anemia,Vitamin B12 deficiency due to low intake from food,Thyrotoxicosis, Hemorrhage, Malignancy, Liver or kidney disease,Gastric bypass surgery, Total or partial gastrectomy, Gluten enteropathy or sprue, Folic acid deficiency, Macrocytic anaemia
Therapeutic classView
Vitamin-B preparations
PharmacologyView
Vitamin B12 (cyanocobalamin) is required for the maintenance of normal erthropoiesis, nucleprotein and myelin synthesis, cell reproduction and normal growth; Coenzyme; metabolic functions include protein synthesis and carbohydrate metabolism. Plays role in cell replication and hematopoiesis.
DosageView
Usual Adult Dose for Pernicious Anemia
Initial dose: 1000 mcg intramuscularly or deep subcutaneous once a day for 6 to 7 days
If clinical improvement and reticulocyte response is seen from the above dosing:
Usual Adult Dose for B12 Nutritional Deficiency: 25 to 2000 mcg orally daily
Usual Adult Dose for Schilling Test: 1000 mcg intramuscularly is the flushing dose
Usual Pediatric Dose for B12 Nutritional Deficiency: 0.5 to 3 mcg daily
Initial dose: 1000 mcg intramuscularly or deep subcutaneous once a day for 6 to 7 days
If clinical improvement and reticulocyte response is seen from the above dosing:
- 100 mcg every other day for 7 doses, then
- 100 mcg every 3 to 4 days for 2 to 3 weeks, then
- Maintenance dose: 100 to 1000 mcg monthly
Usual Adult Dose for B12 Nutritional Deficiency: 25 to 2000 mcg orally daily
Usual Adult Dose for Schilling Test: 1000 mcg intramuscularly is the flushing dose
Usual Pediatric Dose for B12 Nutritional Deficiency: 0.5 to 3 mcg daily
Side effectsView
Arthralgia (12%), Dizziness (12%), Headache (12%), Nasopharyngitis (12%), Anaphylaxis, Angioedema, Congestive heart failure, Peripheral vascular disease,Pulmonary edema, Diarrhea, Dyspepsia, Polycythemia vera, Sore throat, Nervousness, Rhinitis, Glossitis, Hypoesthesia
ContraindicationsView
Leber's disease, tobacco amblyopia.
PrecautionsView
Intensive treatment of B12-deficient megaloblastic anemia may cause hypokalemia and sudden death. Use with caution in patients with Leber optic nerve atrophy. Thrombocytosis may occur with treatment of severe vitamin B12 megaloblastic anemia
InteractionsView
Absorption reduced by antibiotics, aminosalicylic acid, anticonvulsants, biguanides, cholestyramine, cimetidine, colchicine, K salts, methyldopa.
Pregnancy & lactationView
Pregnancy Category A. Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Lactation: Drug distributed in milk.
Lactation: Drug distributed in milk.
Cynomin
Cyanocobalamin
Cynomin
Cyanocobalamin
Indications
Vitamin B12 deficiency
Indication detailsView
This preparation is indicated in Pernicious anemia,Vitamin B12 deficiency due to low intake from food,Thyrotoxicosis, Hemorrhage, Malignancy, Liver or kidney disease,Gastric bypass surgery, Total or partial gastrectomy, Gluten enteropathy or sprue, Folic acid deficiency, Macrocytic anaemia
Therapeutic classView
Vitamin-B preparations
PharmacologyView
Vitamin B12 (cyanocobalamin) is required for the maintenance of normal erthropoiesis, nucleprotein and myelin synthesis, cell reproduction and normal growth; Coenzyme; metabolic functions include protein synthesis and carbohydrate metabolism. Plays role in cell replication and hematopoiesis.
DosageView
Usual Adult Dose for Pernicious Anemia
Initial dose: 1000 mcg intramuscularly or deep subcutaneous once a day for 6 to 7 days
If clinical improvement and reticulocyte response is seen from the above dosing:
Usual Adult Dose for B12 Nutritional Deficiency: 25 to 2000 mcg orally daily
Usual Adult Dose for Schilling Test: 1000 mcg intramuscularly is the flushing dose
Usual Pediatric Dose for B12 Nutritional Deficiency: 0.5 to 3 mcg daily
Initial dose: 1000 mcg intramuscularly or deep subcutaneous once a day for 6 to 7 days
If clinical improvement and reticulocyte response is seen from the above dosing:
- 100 mcg every other day for 7 doses, then
- 100 mcg every 3 to 4 days for 2 to 3 weeks, then
- Maintenance dose: 100 to 1000 mcg monthly
Usual Adult Dose for B12 Nutritional Deficiency: 25 to 2000 mcg orally daily
Usual Adult Dose for Schilling Test: 1000 mcg intramuscularly is the flushing dose
Usual Pediatric Dose for B12 Nutritional Deficiency: 0.5 to 3 mcg daily
Side effectsView
Arthralgia (12%), Dizziness (12%), Headache (12%), Nasopharyngitis (12%), Anaphylaxis, Angioedema, Congestive heart failure, Peripheral vascular disease,Pulmonary edema, Diarrhea, Dyspepsia, Polycythemia vera, Sore throat, Nervousness, Rhinitis, Glossitis, Hypoesthesia
ContraindicationsView
Leber's disease, tobacco amblyopia.
PrecautionsView
Intensive treatment of B12-deficient megaloblastic anemia may cause hypokalemia and sudden death. Use with caution in patients with Leber optic nerve atrophy. Thrombocytosis may occur with treatment of severe vitamin B12 megaloblastic anemia
InteractionsView
Absorption reduced by antibiotics, aminosalicylic acid, anticonvulsants, biguanides, cholestyramine, cimetidine, colchicine, K salts, methyldopa.
Pregnancy & lactationView
Pregnancy Category A. Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Lactation: Drug distributed in milk.
Lactation: Drug distributed in milk.
Cynomin-H
Hydroxocobalamin
Cynomin-H
Hydroxocobalamin
Indications
Pernicious anemia
Indication detailsView
Hydroxocobalamin is indicated for the treatment of known or suspected cyanide poisoning.
Identifying Patients with Cyanide Poisoning: Cyanide poisoning may result from inhalation, ingestion, or dermal exposure to various cyanide-containing compounds, including smoke from closed-space fires. Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogenic plants, aliphatic nitriles, and prolonged exposure to sodium nitroprusside.
The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and signs and symptoms of cyanide intoxication. If clinical suspicion of cyanide poisoning is high, Hydroxocobalamin should be administered without delay.
In some settings, panic symptoms including tachypnea and vomiting may mimic early cyanide poisoning signs. The presence of altered mental status (e.g., confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning although these signs can occur with other toxic exposures as well.
Smoke Inhalation: Not all smoke inhalation victims will have cyanide poisoning and may present with burns, trauma, and exposure to other toxic substances making a diagnosis of cyanide poisoning particularly difficult. Prior to administration of Hydroxocobalamin, smoke-inhalation victims should be assessed for the following:
Use with Other Cyanide Antidotes: Caution should be exercised when administering other cyanide antidotes simultaneously with Hydroxocobalamin, as the safety of co-administration has not been established. If a decision is made to administer another cyanide antidote with Hydroxocobalamin, these drugs should not be administered concurrently in the same intravenous line.
Identifying Patients with Cyanide Poisoning: Cyanide poisoning may result from inhalation, ingestion, or dermal exposure to various cyanide-containing compounds, including smoke from closed-space fires. Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogenic plants, aliphatic nitriles, and prolonged exposure to sodium nitroprusside.
The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and signs and symptoms of cyanide intoxication. If clinical suspicion of cyanide poisoning is high, Hydroxocobalamin should be administered without delay.
In some settings, panic symptoms including tachypnea and vomiting may mimic early cyanide poisoning signs. The presence of altered mental status (e.g., confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning although these signs can occur with other toxic exposures as well.
Smoke Inhalation: Not all smoke inhalation victims will have cyanide poisoning and may present with burns, trauma, and exposure to other toxic substances making a diagnosis of cyanide poisoning particularly difficult. Prior to administration of Hydroxocobalamin, smoke-inhalation victims should be assessed for the following:
- Exposure to fire or smoke in an enclosed area
- Presence of soot around the mouth, nose or oropharynx
- Altered mental status
Use with Other Cyanide Antidotes: Caution should be exercised when administering other cyanide antidotes simultaneously with Hydroxocobalamin, as the safety of co-administration has not been established. If a decision is made to administer another cyanide antidote with Hydroxocobalamin, these drugs should not be administered concurrently in the same intravenous line.
Therapeutic classView
Antidote preparations, Drugs for Megaloblastic Anemia
PharmacologyView
Vitamin B12 with hydroxyl group complexed to cobalt which can be displaced by cyanide resulting in cyanocobaiamin that is renally excreted.
DosageView
Thirty mcg daily for 5 to 10 days followed by 100 to 200 mcg monthly injected intramuscularly. If the patient is critically ill, or has neurologic disease, an infectious disease or hyperthyroidism, considerably higher doses may be indicated. However, current data indicate that the optimum obtainable neurologic response may be expected with a dosage of vitamin B12 sufficient to produce good hematologic response. Children may be given a total of 1 to 5 mg over a period of 2 or more weeks in doses of 100 mcg, then 30 to 50 mcg every 4 weeks for maintenance.
Side effectsView
Mild transient diarrhea, itching, transitory exanthema, feeling of swelling of entire body, and anaphylaxis. A few patients may experience pain after injection of hydroxocobalamin.
ContraindicationsView
Hypersensitivity to any component of this medication.
PrecautionsView
The validity of diagnostic vitamin B12 or folic acid blood assays could be compromised by medications, and this should be considered before relying on such tests for therapy.
Vitamin B12 is not a substitute for folic acid and since it might improve folic acid deficient megaloblastic anemia, indiscriminate use of vitamin B12 could mask the true diagnosis.
Hypokalemia and thrombocytosis could occur upon conversion of severe megaloblastic to normal erythropoiesis with B12 therapy. Therefore, serum potassium levels and the platelet count should be monitored carefully during therapy.
Vitamin B12 deficiency may suppress the signs of polycythemia vera. Treatment with vitamin B12 may unmask this condition.
Vitamin B12 is not a substitute for folic acid and since it might improve folic acid deficient megaloblastic anemia, indiscriminate use of vitamin B12 could mask the true diagnosis.
Hypokalemia and thrombocytosis could occur upon conversion of severe megaloblastic to normal erythropoiesis with B12 therapy. Therefore, serum potassium levels and the platelet count should be monitored carefully during therapy.
Vitamin B12 deficiency may suppress the signs of polycythemia vera. Treatment with vitamin B12 may unmask this condition.
InteractionsView
- history of interaction with ARI Sodium Iodide (II23) 1 -12 MBq (sodium iodide i-123)
- ARI Sodium Iodide (1123) 100-750 MBq (sodium iodide i-123) arsenic trioxide
- Chloracol (chloramphenicol) chloramphenicol
- Chloromycetin (chloramphenicol)
- Chloromycetin Sodium Succinate (chloramphenicol)
- Hicon (sodium iodide-i-131) lodotope (sodium iodide-i-131) sodium iodide i-123 sodium iodide-i-131 Trisenox (arsenic trioxide)
Pregnancy & lactationView
Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
StorageView
Should be stored in cool and dry place
Cynovit
Cyanocobalamin
Cynovit
Cyanocobalamin
Indications
Vitamin B12 deficiency
Indication detailsView
This preparation is indicated in Pernicious anemia,Vitamin B12 deficiency due to low intake from food,Thyrotoxicosis, Hemorrhage, Malignancy, Liver or kidney disease,Gastric bypass surgery, Total or partial gastrectomy, Gluten enteropathy or sprue, Folic acid deficiency, Macrocytic anaemia
Therapeutic classView
Vitamin-B preparations
PharmacologyView
Vitamin B12 (cyanocobalamin) is required for the maintenance of normal erthropoiesis, nucleprotein and myelin synthesis, cell reproduction and normal growth; Coenzyme; metabolic functions include protein synthesis and carbohydrate metabolism. Plays role in cell replication and hematopoiesis.
DosageView
Usual Adult Dose for Pernicious Anemia
Initial dose: 1000 mcg intramuscularly or deep subcutaneous once a day for 6 to 7 days
If clinical improvement and reticulocyte response is seen from the above dosing:
Usual Adult Dose for B12 Nutritional Deficiency: 25 to 2000 mcg orally daily
Usual Adult Dose for Schilling Test: 1000 mcg intramuscularly is the flushing dose
Usual Pediatric Dose for B12 Nutritional Deficiency: 0.5 to 3 mcg daily
Initial dose: 1000 mcg intramuscularly or deep subcutaneous once a day for 6 to 7 days
If clinical improvement and reticulocyte response is seen from the above dosing:
- 100 mcg every other day for 7 doses, then
- 100 mcg every 3 to 4 days for 2 to 3 weeks, then
- Maintenance dose: 100 to 1000 mcg monthly
Usual Adult Dose for B12 Nutritional Deficiency: 25 to 2000 mcg orally daily
Usual Adult Dose for Schilling Test: 1000 mcg intramuscularly is the flushing dose
Usual Pediatric Dose for B12 Nutritional Deficiency: 0.5 to 3 mcg daily
Side effectsView
Arthralgia (12%), Dizziness (12%), Headache (12%), Nasopharyngitis (12%), Anaphylaxis, Angioedema, Congestive heart failure, Peripheral vascular disease,Pulmonary edema, Diarrhea, Dyspepsia, Polycythemia vera, Sore throat, Nervousness, Rhinitis, Glossitis, Hypoesthesia
ContraindicationsView
Leber's disease, tobacco amblyopia.
PrecautionsView
Intensive treatment of B12-deficient megaloblastic anemia may cause hypokalemia and sudden death. Use with caution in patients with Leber optic nerve atrophy. Thrombocytosis may occur with treatment of severe vitamin B12 megaloblastic anemia
InteractionsView
Absorption reduced by antibiotics, aminosalicylic acid, anticonvulsants, biguanides, cholestyramine, cimetidine, colchicine, K salts, methyldopa.
Pregnancy & lactationView
Pregnancy Category A. Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Lactation: Drug distributed in milk.
Lactation: Drug distributed in milk.
Cynta
Tapentadol Hydrochloride
Cynta
Tapentadol Hydrochloride
Indications
Pain
Indication detailsView
Tapentadol is indicated for the relief of moderate to severe acute pain in patients 18 years of age or older.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tapentadol is a centrally-acting synthetic analgesic. It is 18 times less potent than morphine in terms of binding to human mu-opioid receptors. It also increases norepinephrine concentrations in the brains of rats via inhibition of norepinephrine reuptake. Selective mu-opioid antagonists like naloxone can block analgesia from tapentadol. It also has not effect on the QT interval.
Tapendadol causes large increases in levels of extracellular norepinephrine (NE) due to a dual mechanism of action involving mu opioid receptor (MOR) agonism as well as noradrenaline reuptake inhibition.
Tapendadol causes large increases in levels of extracellular norepinephrine (NE) due to a dual mechanism of action involving mu opioid receptor (MOR) agonism as well as noradrenaline reuptake inhibition.
DosageView
As with many centrally-acting analgesic medications, the dosing regimen should be individualized according to the severity of pain being treated, the previous experience with similar drugs and the ability to monitor the patient.
The dose is 50 mg, 75 mg, or 100 mg every 4 to 6 hours depending upon pain intensity. On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability.
Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are not recommended.
The dose is 50 mg, 75 mg, or 100 mg every 4 to 6 hours depending upon pain intensity. On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability.
Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are not recommended.
Side effectsView
The following treatment-emergent adverse events may happen: heart rate increased, heart rate decreased, visual disturbance, abdominal discomfort, impaired gastric emptying, irritability, edema, drug withdrawal syndrome, hypersensitivity, involuntary muscle contractions, sensation of heaviness, hypoesthesia, paresthesia, disturbance in attention, sedation, dysarthria, memory impairment, ataxia, presyncope, syncope, coordination abnormal, seizure, urticaria, blood pressure decreased etc.
ContraindicationsView
This drug is contraindicated in patients with impaired Pulmonary Function, It is also contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment. This drug is contraindicated in any patient who has or is suspected of having paralytic ileus.
PrecautionsView
Tapentadol should be administered with caution to patients with conditions accompanied by hypoxia, hypercapnia respiratory problems such as: asthma, chronic obstructive pulmonary disease etc. Besides this in case of patient with sleep apnea syndrome, myxedema, kyphoscoliosis, central nervous system (CNS) depression should have to be cautious prior administration of Tapentadol. Patients receiving other mu-opioid agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) concomitantly with Tapentadol may exhibit additive CNS depression.
InteractionsView
Increased risk of serotonin syndrome with other drugs that enhance monoaminergic neurotransmission (e.g. TCAs, triptans, SSRIs, serotonin and norepinephrine reuptake inhibitors). Enhanced sedative effect with benzodiazepines, barbiturates, antipsychotics, H1-antihistamines and other opioids. Increased potential for addiction with mixed μ-opioid agonists/antagonists (e.g. nalbuphine, pentazocine) or partial μ-opioid agonists (e.g. buprenorphine). Increased systemic exposure with strong inhibitors of UGT1A6, UGT1A9 and UGT2B7 isoenzymes. Decreased efficacy with strong enzyme inducers (e.g. rifampicin, phenobarbital).
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Neonates whose mothers have been taking Tapentadol should be monitored for respiratory depression.
Neonates whose mothers have been taking Tapentadol should be monitored for respiratory depression.
Pediatric usageView
Pediatric use: The safety and effectiveness of Tapentadol in pediatric patients less than 18 years of age have not been established.
Use in elderly patients: In general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. consideration should be given to starting elderly patients with the lower range of recommended doses.
Use in Renal Disease: In patients with severe renal impairment, the safety and effectiveness of Tapentadol has not been established.
Use in Hepatic Disease: Tapentadol should be used with caution in patients with moderate hepatic impairment. Tapentadol has not been studied in patients with severe hepatic impairment.
Use in elderly patients: In general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. consideration should be given to starting elderly patients with the lower range of recommended doses.
Use in Renal Disease: In patients with severe renal impairment, the safety and effectiveness of Tapentadol has not been established.
Use in Hepatic Disease: Tapentadol should be used with caution in patients with moderate hepatic impairment. Tapentadol has not been studied in patients with severe hepatic impairment.
Overdose effectsView
Symptoms: Vomiting, miosis, CV collapse, consciousness disorders up to coma, convulsions and resp depression up to resp arrest.
Management: Re-establish a patent airway and institute assisted or controlled ventilation. GI decontamination with activated charcoal or by gastric lavage may be considered within 2 hr after intake. Pure opioid receptor antagonists (e.g. naloxone) may be given as antidote.
Management: Re-establish a patent airway and institute assisted or controlled ventilation. GI decontamination with activated charcoal or by gastric lavage may be considered within 2 hr after intake. Pure opioid receptor antagonists (e.g. naloxone) may be given as antidote.
StorageView
Store in a cool and dry place, protected from light and moisture. Keep the medicine out of the reach of children.
Cynta
Tapentadol Hydrochloride
Cynta
Tapentadol Hydrochloride
Indications
Pain
Indication detailsView
Tapentadol is indicated for the relief of moderate to severe acute pain in patients 18 years of age or older.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tapentadol is a centrally-acting synthetic analgesic. It is 18 times less potent than morphine in terms of binding to human mu-opioid receptors. It also increases norepinephrine concentrations in the brains of rats via inhibition of norepinephrine reuptake. Selective mu-opioid antagonists like naloxone can block analgesia from tapentadol. It also has not effect on the QT interval.
Tapendadol causes large increases in levels of extracellular norepinephrine (NE) due to a dual mechanism of action involving mu opioid receptor (MOR) agonism as well as noradrenaline reuptake inhibition.
Tapendadol causes large increases in levels of extracellular norepinephrine (NE) due to a dual mechanism of action involving mu opioid receptor (MOR) agonism as well as noradrenaline reuptake inhibition.
DosageView
As with many centrally-acting analgesic medications, the dosing regimen should be individualized according to the severity of pain being treated, the previous experience with similar drugs and the ability to monitor the patient.
The dose is 50 mg, 75 mg, or 100 mg every 4 to 6 hours depending upon pain intensity. On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability.
Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are not recommended.
The dose is 50 mg, 75 mg, or 100 mg every 4 to 6 hours depending upon pain intensity. On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability.
Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are not recommended.
Side effectsView
The following treatment-emergent adverse events may happen: heart rate increased, heart rate decreased, visual disturbance, abdominal discomfort, impaired gastric emptying, irritability, edema, drug withdrawal syndrome, hypersensitivity, involuntary muscle contractions, sensation of heaviness, hypoesthesia, paresthesia, disturbance in attention, sedation, dysarthria, memory impairment, ataxia, presyncope, syncope, coordination abnormal, seizure, urticaria, blood pressure decreased etc.
ContraindicationsView
This drug is contraindicated in patients with impaired Pulmonary Function, It is also contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment. This drug is contraindicated in any patient who has or is suspected of having paralytic ileus.
PrecautionsView
Tapentadol should be administered with caution to patients with conditions accompanied by hypoxia, hypercapnia respiratory problems such as: asthma, chronic obstructive pulmonary disease etc. Besides this in case of patient with sleep apnea syndrome, myxedema, kyphoscoliosis, central nervous system (CNS) depression should have to be cautious prior administration of Tapentadol. Patients receiving other mu-opioid agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) concomitantly with Tapentadol may exhibit additive CNS depression.
InteractionsView
Increased risk of serotonin syndrome with other drugs that enhance monoaminergic neurotransmission (e.g. TCAs, triptans, SSRIs, serotonin and norepinephrine reuptake inhibitors). Enhanced sedative effect with benzodiazepines, barbiturates, antipsychotics, H1-antihistamines and other opioids. Increased potential for addiction with mixed μ-opioid agonists/antagonists (e.g. nalbuphine, pentazocine) or partial μ-opioid agonists (e.g. buprenorphine). Increased systemic exposure with strong inhibitors of UGT1A6, UGT1A9 and UGT2B7 isoenzymes. Decreased efficacy with strong enzyme inducers (e.g. rifampicin, phenobarbital).
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Neonates whose mothers have been taking Tapentadol should be monitored for respiratory depression.
Neonates whose mothers have been taking Tapentadol should be monitored for respiratory depression.
Pediatric usageView
Pediatric use: The safety and effectiveness of Tapentadol in pediatric patients less than 18 years of age have not been established.
Use in elderly patients: In general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. consideration should be given to starting elderly patients with the lower range of recommended doses.
Use in Renal Disease: In patients with severe renal impairment, the safety and effectiveness of Tapentadol has not been established.
Use in Hepatic Disease: Tapentadol should be used with caution in patients with moderate hepatic impairment. Tapentadol has not been studied in patients with severe hepatic impairment.
Use in elderly patients: In general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. consideration should be given to starting elderly patients with the lower range of recommended doses.
Use in Renal Disease: In patients with severe renal impairment, the safety and effectiveness of Tapentadol has not been established.
Use in Hepatic Disease: Tapentadol should be used with caution in patients with moderate hepatic impairment. Tapentadol has not been studied in patients with severe hepatic impairment.
Overdose effectsView
Symptoms: Vomiting, miosis, CV collapse, consciousness disorders up to coma, convulsions and resp depression up to resp arrest.
Management: Re-establish a patent airway and institute assisted or controlled ventilation. GI decontamination with activated charcoal or by gastric lavage may be considered within 2 hr after intake. Pure opioid receptor antagonists (e.g. naloxone) may be given as antidote.
Management: Re-establish a patent airway and institute assisted or controlled ventilation. GI decontamination with activated charcoal or by gastric lavage may be considered within 2 hr after intake. Pure opioid receptor antagonists (e.g. naloxone) may be given as antidote.
StorageView
Store in a cool and dry place, protected from light and moisture. Keep the medicine out of the reach of children.
Cynta
Tapentadol Hydrochloride
Cynta
Tapentadol Hydrochloride
Indications
Pain
Indication detailsView
Tapentadol is indicated for the relief of moderate to severe acute pain in patients 18 years of age or older.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tapentadol is a centrally-acting synthetic analgesic. It is 18 times less potent than morphine in terms of binding to human mu-opioid receptors. It also increases norepinephrine concentrations in the brains of rats via inhibition of norepinephrine reuptake. Selective mu-opioid antagonists like naloxone can block analgesia from tapentadol. It also has not effect on the QT interval.
Tapendadol causes large increases in levels of extracellular norepinephrine (NE) due to a dual mechanism of action involving mu opioid receptor (MOR) agonism as well as noradrenaline reuptake inhibition.
Tapendadol causes large increases in levels of extracellular norepinephrine (NE) due to a dual mechanism of action involving mu opioid receptor (MOR) agonism as well as noradrenaline reuptake inhibition.
DosageView
As with many centrally-acting analgesic medications, the dosing regimen should be individualized according to the severity of pain being treated, the previous experience with similar drugs and the ability to monitor the patient.
The dose is 50 mg, 75 mg, or 100 mg every 4 to 6 hours depending upon pain intensity. On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability.
Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are not recommended.
The dose is 50 mg, 75 mg, or 100 mg every 4 to 6 hours depending upon pain intensity. On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability.
Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are not recommended.
Side effectsView
The following treatment-emergent adverse events may happen: heart rate increased, heart rate decreased, visual disturbance, abdominal discomfort, impaired gastric emptying, irritability, edema, drug withdrawal syndrome, hypersensitivity, involuntary muscle contractions, sensation of heaviness, hypoesthesia, paresthesia, disturbance in attention, sedation, dysarthria, memory impairment, ataxia, presyncope, syncope, coordination abnormal, seizure, urticaria, blood pressure decreased etc.
ContraindicationsView
This drug is contraindicated in patients with impaired Pulmonary Function, It is also contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment. This drug is contraindicated in any patient who has or is suspected of having paralytic ileus.
PrecautionsView
Tapentadol should be administered with caution to patients with conditions accompanied by hypoxia, hypercapnia respiratory problems such as: asthma, chronic obstructive pulmonary disease etc. Besides this in case of patient with sleep apnea syndrome, myxedema, kyphoscoliosis, central nervous system (CNS) depression should have to be cautious prior administration of Tapentadol. Patients receiving other mu-opioid agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) concomitantly with Tapentadol may exhibit additive CNS depression.
InteractionsView
Increased risk of serotonin syndrome with other drugs that enhance monoaminergic neurotransmission (e.g. TCAs, triptans, SSRIs, serotonin and norepinephrine reuptake inhibitors). Enhanced sedative effect with benzodiazepines, barbiturates, antipsychotics, H1-antihistamines and other opioids. Increased potential for addiction with mixed μ-opioid agonists/antagonists (e.g. nalbuphine, pentazocine) or partial μ-opioid agonists (e.g. buprenorphine). Increased systemic exposure with strong inhibitors of UGT1A6, UGT1A9 and UGT2B7 isoenzymes. Decreased efficacy with strong enzyme inducers (e.g. rifampicin, phenobarbital).
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Neonates whose mothers have been taking Tapentadol should be monitored for respiratory depression.
Neonates whose mothers have been taking Tapentadol should be monitored for respiratory depression.
Pediatric usageView
Pediatric use: The safety and effectiveness of Tapentadol in pediatric patients less than 18 years of age have not been established.
Use in elderly patients: In general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. consideration should be given to starting elderly patients with the lower range of recommended doses.
Use in Renal Disease: In patients with severe renal impairment, the safety and effectiveness of Tapentadol has not been established.
Use in Hepatic Disease: Tapentadol should be used with caution in patients with moderate hepatic impairment. Tapentadol has not been studied in patients with severe hepatic impairment.
Use in elderly patients: In general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. consideration should be given to starting elderly patients with the lower range of recommended doses.
Use in Renal Disease: In patients with severe renal impairment, the safety and effectiveness of Tapentadol has not been established.
Use in Hepatic Disease: Tapentadol should be used with caution in patients with moderate hepatic impairment. Tapentadol has not been studied in patients with severe hepatic impairment.
Overdose effectsView
Symptoms: Vomiting, miosis, CV collapse, consciousness disorders up to coma, convulsions and resp depression up to resp arrest.
Management: Re-establish a patent airway and institute assisted or controlled ventilation. GI decontamination with activated charcoal or by gastric lavage may be considered within 2 hr after intake. Pure opioid receptor antagonists (e.g. naloxone) may be given as antidote.
Management: Re-establish a patent airway and institute assisted or controlled ventilation. GI decontamination with activated charcoal or by gastric lavage may be considered within 2 hr after intake. Pure opioid receptor antagonists (e.g. naloxone) may be given as antidote.
StorageView
Store in a cool and dry place, protected from light and moisture. Keep the medicine out of the reach of children.
Cyphos
Cyclophosphamide
Cyphos
Cyclophosphamide
Indications
Vasculitis
Indication detailsView
Malignant Diseases:
Cyclophosphamide is indicated for the treatment of:- Malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma
- Multiple myeloma
- Leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenousand monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration)
- Mycosis fungoides (advanced disease)
- Neuroblastoma (disseminated disease)
- Adenocarcinoma of the ovary
- Retinoblastoma
- Carcinoma of the breast
Minimal Change Nephrotic Syndrome in Pediatric Patients:
Cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy.Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Cyclophosphamide is a prodrug which is converted in the body to the active metabolites. It acts at any stage of the cell cycle. It prevents cell division by cross-linking deoxyribonucleic acid (DNA) strands and reducing DNA synthesis. It also exerts a potent immunosuppressive effect.
DosageView
Intravenous (Adult)-
Malignancies:- Low dose regimen: 2-6 mg/kg wkly as a single dose;
- Moderate dose regimen: 10-15 mg/kg wkly as a single dose;
- High dose regimen: 20-40 mg/kg as a single dose every 10-20 days.
- 80-300 mg/m2 daily as a single dose, or
- 300-600 mg/m2 wkly as a single dose, or
- 600-1,500 mg/m2 as a single dose or
- Short infusion at 10- to 20-day intervals.
Oral (Child)-
Nephrotic syndrome:- 2 mg/kg daily for 8-12 wk.
- Max cumulative dose: 168 mg/kg.
- Max duration: 90 days.
Oral (Adult)-
Malignancies:- Low dose regimen: 2-6 mg/kg wkly in divided dose.
- Alternatively, 100-300 mg daily in divided doses, or
- 50-250 mg/m2 daily or 80-300 mg/m2 daily in divided doses.
AdministrationView
Should be taken on an empty stomach. Preferably taken on an empty stomach, but may be taken with meals to minimise GI irritation. Ensure adequate fluid intake. Swallow whole.
Side effectsView
Alopecia, skin and nails hyperpigmentation, nausea and vomiting, mucositis, inappropriate antidiuretic hormone secretion, carbohydrate metabolism disturbances, gonadal suppression, interstitial pulmonary fibrosis.
ContraindicationsView
Patient with bone marrow aplasia, urinary outflow obstruction, UTI, acute infection, drug- or radiation-induced urothelial toxicity. Pregnancy.
PrecautionsView
Patient with DM, severe immunosuppression, acute porphyria, pre-existing CV disease or those at risk for cardiotoxicity. Renal and hepatic impairment. Lactation.
InteractionsView
Increased risk of cardiotoxicity with doxorubicin or other cardiotoxic drugs. May increase incidence of mucositis with protease inhibitors. May increase haematotoxicity and/or immunosuppression with ACE inhibitors, natalizumab, paclitaxel, thiazide diuretics, zidovudine. May increase pulmonary toxicity with amiodarone. May increase nephrotoxicity with amphotericin B. May result to acute water intoxication with indometacin. May increase risk of hepatotoxicity with azathioprine. May increase incidence of hepatic veno-occlusive disease and mucositis with busulfan. May increase risk of haemorrhagic cystitis with previous or concomitant radiotherapy. May result to acute encephalopathy with metronidazole. May increase risk of thromboembolic complications. May alter the effect of warfarin. May increase immunosuppressive effect of ciclosporin. May result to prolonged apnoea with depolarising muscle relaxants (e.g. suxamethonium).
Pregnancy & lactationView
Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Overdose effectsView
Symptoms: Urotoxicity, myelosuppression, cardiotoxicity (including cardiac failure), stomatitis, veno-occlusive hepatic disease.
Management: Supportive treatment. May consider haemodialysis. Cystitis prophylaxis with mesna may be useful for urotoxicity.
Management: Supportive treatment. May consider haemodialysis. Cystitis prophylaxis with mesna may be useful for urotoxicity.
ReconstitutionView
Reconstitute with 25 mL for a 500 mg vial, 50 mL for a 1,000 mg vial or 100 mL for a 2,000 mg vial to a concentration of 20 mg/mL using NaCl 0.9% for direct IV push, or NaCl 0.9% or sterile water for inj for IV infusion. Gently swirl to mix. For IV infusion, dilute further with dextrose 5% in water, NaCl 0.45% or dextrose 5% and NaCl 0.9% inj to a minimum concentration of 2 mg/mL.
StorageView
Store at or below 25°C.
Cyphos
Cyclophosphamide
Cyphos
Cyclophosphamide
Indications
Vasculitis
Indication detailsView
Malignant Diseases:
Cyclophosphamide is indicated for the treatment of:- Malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma
- Multiple myeloma
- Leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenousand monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration)
- Mycosis fungoides (advanced disease)
- Neuroblastoma (disseminated disease)
- Adenocarcinoma of the ovary
- Retinoblastoma
- Carcinoma of the breast
Minimal Change Nephrotic Syndrome in Pediatric Patients:
Cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy.Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Cyclophosphamide is a prodrug which is converted in the body to the active metabolites. It acts at any stage of the cell cycle. It prevents cell division by cross-linking deoxyribonucleic acid (DNA) strands and reducing DNA synthesis. It also exerts a potent immunosuppressive effect.
DosageView
Intravenous (Adult)-
Malignancies:- Low dose regimen: 2-6 mg/kg wkly as a single dose;
- Moderate dose regimen: 10-15 mg/kg wkly as a single dose;
- High dose regimen: 20-40 mg/kg as a single dose every 10-20 days.
- 80-300 mg/m2 daily as a single dose, or
- 300-600 mg/m2 wkly as a single dose, or
- 600-1,500 mg/m2 as a single dose or
- Short infusion at 10- to 20-day intervals.
Oral (Child)-
Nephrotic syndrome:- 2 mg/kg daily for 8-12 wk.
- Max cumulative dose: 168 mg/kg.
- Max duration: 90 days.
Oral (Adult)-
Malignancies:- Low dose regimen: 2-6 mg/kg wkly in divided dose.
- Alternatively, 100-300 mg daily in divided doses, or
- 50-250 mg/m2 daily or 80-300 mg/m2 daily in divided doses.
AdministrationView
Should be taken on an empty stomach. Preferably taken on an empty stomach, but may be taken with meals to minimise GI irritation. Ensure adequate fluid intake. Swallow whole.
Side effectsView
Alopecia, skin and nails hyperpigmentation, nausea and vomiting, mucositis, inappropriate antidiuretic hormone secretion, carbohydrate metabolism disturbances, gonadal suppression, interstitial pulmonary fibrosis.
ContraindicationsView
Patient with bone marrow aplasia, urinary outflow obstruction, UTI, acute infection, drug- or radiation-induced urothelial toxicity. Pregnancy.
PrecautionsView
Patient with DM, severe immunosuppression, acute porphyria, pre-existing CV disease or those at risk for cardiotoxicity. Renal and hepatic impairment. Lactation.
InteractionsView
Increased risk of cardiotoxicity with doxorubicin or other cardiotoxic drugs. May increase incidence of mucositis with protease inhibitors. May increase haematotoxicity and/or immunosuppression with ACE inhibitors, natalizumab, paclitaxel, thiazide diuretics, zidovudine. May increase pulmonary toxicity with amiodarone. May increase nephrotoxicity with amphotericin B. May result to acute water intoxication with indometacin. May increase risk of hepatotoxicity with azathioprine. May increase incidence of hepatic veno-occlusive disease and mucositis with busulfan. May increase risk of haemorrhagic cystitis with previous or concomitant radiotherapy. May result to acute encephalopathy with metronidazole. May increase risk of thromboembolic complications. May alter the effect of warfarin. May increase immunosuppressive effect of ciclosporin. May result to prolonged apnoea with depolarising muscle relaxants (e.g. suxamethonium).
Pregnancy & lactationView
Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Overdose effectsView
Symptoms: Urotoxicity, myelosuppression, cardiotoxicity (including cardiac failure), stomatitis, veno-occlusive hepatic disease.
Management: Supportive treatment. May consider haemodialysis. Cystitis prophylaxis with mesna may be useful for urotoxicity.
Management: Supportive treatment. May consider haemodialysis. Cystitis prophylaxis with mesna may be useful for urotoxicity.
ReconstitutionView
Reconstitute with 25 mL for a 500 mg vial, 50 mL for a 1,000 mg vial or 100 mL for a 2,000 mg vial to a concentration of 20 mg/mL using NaCl 0.9% for direct IV push, or NaCl 0.9% or sterile water for inj for IV infusion. Gently swirl to mix. For IV infusion, dilute further with dextrose 5% in water, NaCl 0.45% or dextrose 5% and NaCl 0.9% inj to a minimum concentration of 2 mg/mL.
StorageView
Store at or below 25°C.
Cyporin
Cyclosporine (Ophthalmic)
Cyporin
Cyclosporine (Ophthalmic)
Indications
Scleritis
Indication detailsView
Cyclosporine Ophthalmic Emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with dry eye syndrome (keratoconjunctivitis sicca).
In addition to this, several clinical studies have showed that cyclosporine is effective in the management of different eye diseases like vernal keratoconjunctivitis, posterior blepharitis, non-infectious uveitis, superior limbic keratoconjunctivitis, phlyctenular keratoconjunctivitis and meibomian gland diseases.
In addition to this, several clinical studies have showed that cyclosporine is effective in the management of different eye diseases like vernal keratoconjunctivitis, posterior blepharitis, non-infectious uveitis, superior limbic keratoconjunctivitis, phlyctenular keratoconjunctivitis and meibomian gland diseases.
Therapeutic classView
Drugs for Dry eyes
PharmacologyView
Cyclosporine is an immunosuppressive agent when administered systemically. In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, topical Cyclosporine is thought to act as a partial immunomodulator.
DosageView
One drop of Cyclosporine eye drop should be instilled twice a day in each eye approximately 12 hours apart. Cyclosporine eye drop can be used concomitantly with artificial tears, allowing a 15-minute interval between products.
Side effectsView
The most common adverse event was ocular burning. Other events reported included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).
ContraindicationsView
Cyclosporine is contraindicated in patients with active ocular infections and in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.
PrecautionsView
Cyclosporine eye drop should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. If contact lenses are worn, they should be removed prior to the administration of this formulation. Lenses may be reinserted 15 minutes following administration of Cyclosporine eye drop.
Pregnancy & lactationView
Pregnancy: There are no adequate and well-controlled studies of Cyclosporine Ophthalmic Emulsion in pregnant women. It should be administered to pregnant women if clearly needed.
Lactation: Cyclosporine is known to be excreted in human milk following systemic administration but excretion in human milk after topical treatment has not been investigated. Although blood concentrations are undetectable after topical administration of Cyclosporine eye drop, caution should be exercised when Cyclosporine is administered to a nursing woman.
Lactation: Cyclosporine is known to be excreted in human milk following systemic administration but excretion in human milk after topical treatment has not been investigated. Although blood concentrations are undetectable after topical administration of Cyclosporine eye drop, caution should be exercised when Cyclosporine is administered to a nursing woman.
Cyramza
Ramucirumab
Cyramza
Ramucirumab
Indications
Non-small cell lung cancer
Indication detailsView
Ramucirumab is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated:
- As a single agent or in combination with paclitaxel, for treatment of advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
- In combination with erlotinib, for first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
- In combination with docetaxel, for treatment of metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Ramucirumab.
- In combination with FOLFIRI, for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
- As a single agent, for the treatment of hepatocellular carcinoma in patients who have an alpha-fetoprotein of ≥400 ng/mL and have been treated with sorafenib.
Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Ramucirumab is a VEGFR2 antagonist that specifically binds VEGFR2 and blocks binding of VEGFR ligands, VEGF-A, VEGF-C, and VEGF-D. As a result, ramucirumab inhibits ligand-stimulated activation of VEGFR2, thereby inhibiting ligand-induced proliferation, and migration of human endothelial cells. Ramucirumab inhibited angiogenesis in an in vivo animal model.
DosageView
For intravenous infusion only. Do not administer as an intravenous push or bolus. Premedicate before each infusion.
- Gastric Cancer: Administer Ramucirumab 8 mg/kg every 2 weeks as a single agent or in combination with weekly paclitaxel.
- Non-Small Cell Lung Cancer: Administer Ramucirumab 10 mg/kg every 2 weeks with daily erlotinib. Administer Ramucirumab 10 mg/kg on Day 1 of a 21-day cycle prior to docetaxel.
- Colorectal Cancer: Administer Ramucirumab 8 mg/kg every 2 weeks prior to FOLFIRI.
- Hepatocellular Carcinoma: Administer Ramucirumab 8 mg/kg every 2 weeks.
Side effectsView
The most common adverse reactions observed in single agent Ramucirumab-treated gastric cancer patients at a rate of ≥10% and ≥2% higher than placebo were hypertension and diarrhea.
The most common adverse reactions observed in patients treated with Ramucirumab with paclitaxel at a rate of ≥30% and ≥2% higher than placebo with paclitaxel were fatigue/asthenia, neutropenia, diarrhea, and epistaxis.
The most common adverse reactions observed in patients treated with Ramucirumab with erlotinib at a rate of ≥30% and ≥2% higher than placebo with erlotinib were, infections, hypertension, stomatitis, proteinuria, alopecia, and epistaxis. The most common laboratory abnormalities at a rate of ≥30% and ≥2% higher difference in incidence between arms were increased alanine aminotransferase, increased aspartate aminotransferase, anemia, thrombocytopenia, and neutropenia.
The most common adverse reactions observed in patients treated with Ramucirumab with docetaxel at a rate of ≥30% and ≥2% higher than placebo with docetaxel were neutropenia, fatigue/asthenia, and stomatitis/mucosal inflammation.
The most common adverse reactions observed in patients treated with Ramucirumab with FOLFIRI at a rate of ≥30% and ≥2% higher than placebo with FOLFIRI were diarrhea, neutropenia, decreased appetite, epistaxis, and stomatitis.
The most common adverse reactions observed in single agent Ramucirumab-treated HCC patients at a rate of ≥15% and ≥2% higher than placebo were fatigue, peripheral edema, hypertension, abdominal pain, decreased appetite, proteinuria, nausea, and ascites. The most common laboratory abnormalities at a rate of ≥30% and a ≥2% higher difference in incidence between arms were thrombocytopenia, hypoalbuminemia, and hyponatremia.
The most common adverse reactions observed in patients treated with Ramucirumab with paclitaxel at a rate of ≥30% and ≥2% higher than placebo with paclitaxel were fatigue/asthenia, neutropenia, diarrhea, and epistaxis.
The most common adverse reactions observed in patients treated with Ramucirumab with erlotinib at a rate of ≥30% and ≥2% higher than placebo with erlotinib were, infections, hypertension, stomatitis, proteinuria, alopecia, and epistaxis. The most common laboratory abnormalities at a rate of ≥30% and ≥2% higher difference in incidence between arms were increased alanine aminotransferase, increased aspartate aminotransferase, anemia, thrombocytopenia, and neutropenia.
The most common adverse reactions observed in patients treated with Ramucirumab with docetaxel at a rate of ≥30% and ≥2% higher than placebo with docetaxel were neutropenia, fatigue/asthenia, and stomatitis/mucosal inflammation.
The most common adverse reactions observed in patients treated with Ramucirumab with FOLFIRI at a rate of ≥30% and ≥2% higher than placebo with FOLFIRI were diarrhea, neutropenia, decreased appetite, epistaxis, and stomatitis.
The most common adverse reactions observed in single agent Ramucirumab-treated HCC patients at a rate of ≥15% and ≥2% higher than placebo were fatigue, peripheral edema, hypertension, abdominal pain, decreased appetite, proteinuria, nausea, and ascites. The most common laboratory abnormalities at a rate of ≥30% and a ≥2% higher difference in incidence between arms were thrombocytopenia, hypoalbuminemia, and hyponatremia.
PrecautionsView
Hemorrhage: Ramucirumab increases the risk of hemorrhage and gastrointestinal hemorrhage, including severe and fatal events. Permanently discontinue Ramucirumab in patients who experience severe bleeding.
Gastrointestinal Perforations: Ramucirumab increases the risk of gastrointestinal perforation, which can be fatal. Permanently discontinue Ramucirumab in patients who experience a gastrointestinal perforation.
Impaired Wound Healing: Withhold Ramucirumab for 28 days prior to elective surgery. Do not administer Ramucirumab for at least 2 weeks following a major surgical procedure and until adequate wound healing. The safety of resumption of Ramucirumab after resolution of wound healing complications has not been established.
Arterial Thromboembolic Events (ATEs): Serious and sometimes fatal ATEs can occur with Ramucirumab. Permanently discontinue Ramucirumab in patients who experience an ATE.
Hypertension: Monitor blood pressure and treat hypertension. Withhold Ramucirumab for severe hypertension. Permanently discontinue Ramucirumab for hypertension that cannot be controlled with antihypertensive therapy and for hypertensive crisis or hypertensive encephalopathy.
Infusion-Related Reactions (IRR): Monitor for signs and symptoms during infusion. Reduce the infusion rate for Grade 1 or 2 IRR and permanently discontinue for Grade 3 or 4 IRR.
Worsening of Pre-existing Hepatic Impairment: New onset or worsening encephalopathy, ascites or hepatorenal syndrome can occur in patients with Child-Pugh B or C cirrhosis.
Posterior Reversible Encephalopathy Syndrome: Permanently discontinue Ramucirumab.
Proteinuria Including Nephrotic Syndrome: Monitor for proteinuria. Withhold Ramucirumab for urine protein levels greater than or equal to 2 g per 24 hours. Permanently discontinue Ramucirumab for urine protein levels greater than 3 g per 24 hours or nephrotic syndrome.
Thyroid Dysfunction: Monitor thyroid function during treatment.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
Gastrointestinal Perforations: Ramucirumab increases the risk of gastrointestinal perforation, which can be fatal. Permanently discontinue Ramucirumab in patients who experience a gastrointestinal perforation.
Impaired Wound Healing: Withhold Ramucirumab for 28 days prior to elective surgery. Do not administer Ramucirumab for at least 2 weeks following a major surgical procedure and until adequate wound healing. The safety of resumption of Ramucirumab after resolution of wound healing complications has not been established.
Arterial Thromboembolic Events (ATEs): Serious and sometimes fatal ATEs can occur with Ramucirumab. Permanently discontinue Ramucirumab in patients who experience an ATE.
Hypertension: Monitor blood pressure and treat hypertension. Withhold Ramucirumab for severe hypertension. Permanently discontinue Ramucirumab for hypertension that cannot be controlled with antihypertensive therapy and for hypertensive crisis or hypertensive encephalopathy.
Infusion-Related Reactions (IRR): Monitor for signs and symptoms during infusion. Reduce the infusion rate for Grade 1 or 2 IRR and permanently discontinue for Grade 3 or 4 IRR.
Worsening of Pre-existing Hepatic Impairment: New onset or worsening encephalopathy, ascites or hepatorenal syndrome can occur in patients with Child-Pugh B or C cirrhosis.
Posterior Reversible Encephalopathy Syndrome: Permanently discontinue Ramucirumab.
Proteinuria Including Nephrotic Syndrome: Monitor for proteinuria. Withhold Ramucirumab for urine protein levels greater than or equal to 2 g per 24 hours. Permanently discontinue Ramucirumab for urine protein levels greater than 3 g per 24 hours or nephrotic syndrome.
Thyroid Dysfunction: Monitor thyroid function during treatment.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
Pregnancy & lactationView
Based on its mechanism of action, Ramucirumab can cause fetal harm when administered to a pregnant woman. There are no available data on Ramucirumab use in pregnant women. Animal models link angiogenesis, VEGF and VEGFR2 to critical aspects of female reproduction, embryo-fetal development, and postnatal development. No animal studies have been conducted to evaluate the effect of ramucirumab on reproduction and fetal development. Advise a pregnant woman of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
There is no information on the presence of ramucirumab in human milk or its effects on the breastfed child or on milk production. Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because of the potential risk for serious adverse reactions in breastfed children from ramucirumab, advise women not to breastfeed during treatment with Ramucirumab and for 2 months after the last dose.
There is no information on the presence of ramucirumab in human milk or its effects on the breastfed child or on milk production. Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because of the potential risk for serious adverse reactions in breastfed children from ramucirumab, advise women not to breastfeed during treatment with Ramucirumab and for 2 months after the last dose.
StorageView
Store vials in a refrigerator at 2°C to 8°C in the original carton to protect from light until time of use. Do not freeze or shake the vial.
Cyrin
Cyclobenzaprine Hydrochloride
Cyrin
Cyclobenzaprine Hydrochloride
Indications
Muscle spasm
Indication detailsView
Cyclobenzaprine is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Therapeutic classView
Locally acting Skeletal Muscle Relaxants
PharmacologyView
Cyclobenzaprine, a centrally-acting skeletal muscle relaxant, is structurally related to tricyclic antidepressants, thus they share similar properties. It acts on the brain stem, decreasing tonic-somatic motor activities influencing both the α and δ motor systems. It is used as an adjunct in the symptomatic treatment of painful muscle spasms associated with musculoskeletal conditions.
DosageView
Adult: 5 mg tid, may increase to 10 mg tid if needed. Treatment should not last more than 2-3 wk. Max: 60 mg.
Elderly: Initiate with 5 mg with less frequent dosing.
Pediatric: Safety and effectiveness of Cyclobenzaprine Hydrochloride in pediatric patients below 15 years of age have not been established.
Elderly: Initiate with 5 mg with less frequent dosing.
Pediatric: Safety and effectiveness of Cyclobenzaprine Hydrochloride in pediatric patients below 15 years of age have not been established.
Side effectsView
The adverse reactions reported most frequently with Cyclobenzaprine Hydrochloride are drowsiness, dry mouth and dizziness. The incidence of these common adverse reactions is lower in the surveillance program than in the controlled clinical studies.
ContraindicationsView
Recent MI, arrhythmias, severe liver disease.
PrecautionsView
Because of its atropine-like action, Cyclobenzaprine Hydrochloride should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.
InteractionsView
Plasma concentration may be increased with the use of cimetidine, diltiazem, disulfiram, methylphenidate, ritonavir, and verapamil. Side-effects are increased by adrenaline, amiodarone, general anesthetics, SSRIs, antihistamines, antimuscarinics, antipsychotics, anxiolytics and hypnotics, clozapine, disopyramide, diuretics, flecainide, MAOIs, moclobemide, moxifloxacin, nefopam, nicorandil, noradrenaline, phenothiazine, pimozide, procainamide, propafenone, quinidine, selegiline, sibutramine, sotalol, terfenadine, thioridazine, and tramadol. Effects of adrenergic neurone blockers, clonidine, barbiturates, nitrates, and primidone are reduced while effects of baclofen, opioid analgesics, and thyroid hormones are enhanced with concomitant use of cyclobenzaprine. Carbamazepine and rifampicin may increase metabolism of cyclobenzaprine. Effects may be antagonized by oestrogens. Avoid use with brimonidine, entacapone, artemether with lumefantrine, or sibutramine. CNS effects may be enhanced by other CNS depressants.
Pregnancy & lactationView
Pregnancy category B. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Cyclobenzaprine Hydrochloride is administered to a nursing mother
Pediatric usageView
Dose in hepatic impairment: Cyclobenzaprine should be used with caution in subjects with mild hepatic impairment starting with the 5 mg dose and titrating slowly upward. The use of Cyclobenzaprine in subjects with moderate to severe impairment is not recommended.
Overdose effectsView
Although rare, deaths may occur from over dosage with Cyclobenzaprine Hydrochloride. Signs and symptoms of toxicity may develop rapidly after Cyclobenzaprine overdose; therefore, hospital monitoring is required as soon as possible.
Cystosan
Pentosan Polysulfate Sodium
Cystosan
Pentosan Polysulfate Sodium
Indications
Interstitial cystitis
Indication detailsView
Pentosan polysulfate sodium is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.
Therapeutic classView
Other genito-urinary preparations
PharmacologyView
Pentosan polysulfate is a polymer of xylose hydrogen sulfate and contains two sulfate groups per carbohydrate monomer. It binds Fibroblast growth factors (FGFs) as well as other heparin-binding growth factors. It has been shown to interact also with the heparin-binding site of FGFR-1. It inhibits the growth of SW13 adrenocortical cells transfected with FGF-4 and tumorigenicity of MCF-7 breast carcinoma cells transfected with FGF-1 or FGF-4.
DosageView
The recommended dose of Pentosan Polysulfate Sodium is 300 mg/day taken as one 100 mg capsule orally three times daily. The capsules should be taken with water at least 1 hour before meals or 2 hours after meals. Patients receiving Pentosan Polysulfate Sodium should be reassessed after 3 months. If improvement has not occurred and if limiting adverse events are not present, Pentosan Polysulfate Sodium may be continued for another 3 months. The clinical value and risks of continued treatment in patients whose pain has not improved by 6 months is not known.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 16 years have not been established.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 16 years have not been established.
Side effectsView
Alopecia (4%), diarrhea (4%), nausea (4%), headache (3%), rash (3%), dyspepsia (2%), abdominal pain (2%), liver function abnormalities (1%), dizziness (1%).
ContraindicationsView
Pentosan Polysulfate Sodium is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.
PrecautionsView
Pentosan Polysulfate Sodium is a weak anticoagulant (1/15 the activity of heparin). At a daily dose of 300 mg (n=128), rectal hemorrhage was reported as an adverse event in 6.3% of patients. Bleeding complications of ecchymosis, epistaxis, and gum hemorrhage have been reported. Patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to other therapies such as coumarin anticoagulants, heparin, t-PA, streptokinase, high dose aspirin, or nonsteroidal anti inflammatory drugs) should be evaluated for hemorrhage. Patients with diseases such as aneurysms, thrombocytopenia, hemophilia, gastrointestinal ulcerations, polyps, or diverticula should be carefully evaluated before starting Pentosan Polysulfate Sodium. A similar product that was given subcutaneously, sublingually, or intramuscularly (and not initially metabolized by the liver) is associated with delayed immunoallergic thrombocytopenia with symptoms of thrombosis and hemorrhage. Caution should be exercised when using Pentosan Polysulfate Sodium in patients who have a history of heparin induced thrombocytopenia. Alopecia is associated with pentosan polysulfate and with heparin products. In clinical trials of Pentosan Polysulfate Sodium, alopecia began within the first 4 weeks of treatment. Ninety-seven percent (97%) of the cases of alopecia reported were alopecia areata, limited to a single area on the scalp.
InteractionsView
In a study in which healthy subjects received pentosan polysulfate sodium 100 mg capsule or placebo every 8 hours for 7 days, and were titrated with warfarin to an INR of 1.4 to 1.8, the pharmacokinetic parameters of R-warfarin and S-warfarin were similar in the absence and presence of pentosan polysulfate sodium. INR for warfarin + placebo and warfarin + pentosan polysulfate sodium were comparable.
Pregnancy & lactationView
Pregnancy: Reproduction studies have been performed in mice and rats with intravenous daily doses of 15 mg/kg, and in rabbits with 7.5 mg/kg. These doses are 0.42 and 0.14 times the daily oral human doses of Pentosan Polysulfate Sodium when normalized to body surface area. These studies did not reveal evidence of impaired fertility or harm to the fetus from Pentosan Polysulfate Sodium. Direct in vitro bathing of cultured mouse embryos with pentosan polysulfate sodium (PPS) at a concentration of 1 mg/mL may cause reversible limb bud abnormalities. Adequate and well-controlled studies have not been performed in pregnant women. Because animal studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.
Nursing Mothers: 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 Pentosan Polysulfate Sodium is administered to a nursing woman.
Nursing Mothers: 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 Pentosan Polysulfate Sodium is administered to a nursing woman.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Cytabin
Cytarabine
Cytabin
Cytarabine
Indications
Non-Hodgkin lymphoma
Indication detailsView
Cytarabine is indicated in Leukaemic meningitis, Induction and maintenance of remission in acute leukaemias
Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Cytarabine inhibits deoxyribonucleic acid (DNA) synthesis specifically at the S-phase of the cell cycle. It also has an antiviral and immunosuppressant activity.
DosageView
Intrathecal (Adult)-
Induction and maintenance of remission in acute leukaemias:
- Leukaemic meningitis: 5-75 mg/m2 or 30-100 mg once every 2-7 days to once daily for 4 or 5 days.
- For lymphomatous meningitis: 50 mg every 2 wk for 5 doses, then every 4 wk for 5 doses.
Induction and maintenance of remission in acute leukaemias:
- As monotherapy: 200 mg/m2 daily by continuous IV infusion for 5 days, at intervals of approx 2 wk.
- In combination therapy: 100 mg/m2 bid by rapid IV inj or 100 mg/m2 daily by continuous IV infusion both for 7 days. Maintenance: 1-1.5 mg/kg once or twice wkly via IV or SC.
Side effectsView
Nausea, vomiting, fever, rash, diarrhoea, anorexia, oral and anal inflammation or ulceration, hepatic dysfunction, headache, weakness, confusion, thrombocytopenia, fatigue.
ContraindicationsView
Patient with active meningeal infection.
PrecautionsView
Patient with previous drug-induced bone marrow suppression. Renal or hepatic impairment. Pregnancy and lactation.
InteractionsView
May reduce efficacy of 5-fluorocytosine, digoxin, gentamicin. May increase risk of neurotoxicity with other cytotoxic agents (intrathecal).
Pregnancy & lactationView
Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Overdose effectsView
Symptoms: Irreversible CNS toxicity and death. Severe arachnoiditis including encephalopathy.
Management: Therapy cessation followed by treatment of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics. Maintain vital functions.
Management: Therapy cessation followed by treatment of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics. Maintain vital functions.
ReconstitutionView
Intravenous: Reconstitute with bacteriostatic water for inj (standard-dose), further dilute in 250-1,000 ml NaCl 0.9% or dextrose 5% in water for infusion.
Intrathecal: Reconstitute with preservative free NaCl 0.9%, further dilute with Elliot’s B soln, NaCl 0.9% or lactated Ringer’s inj to preferred final vol (up to 12 ml).
Intrathecal: Reconstitute with preservative free NaCl 0.9%, further dilute with Elliot’s B soln, NaCl 0.9% or lactated Ringer’s inj to preferred final vol (up to 12 ml).
StorageView
IV/SC: Store between 15-25°C. Intrathecal: Store between 2-8°C. Avoid freezing.
Cytabin
Cytarabine
Cytabin
Cytarabine
Indications
Non-Hodgkin lymphoma
Indication detailsView
Cytarabine is indicated in Leukaemic meningitis, Induction and maintenance of remission in acute leukaemias
Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Cytarabine inhibits deoxyribonucleic acid (DNA) synthesis specifically at the S-phase of the cell cycle. It also has an antiviral and immunosuppressant activity.
DosageView
Intrathecal (Adult)-
Induction and maintenance of remission in acute leukaemias:
- Leukaemic meningitis: 5-75 mg/m2 or 30-100 mg once every 2-7 days to once daily for 4 or 5 days.
- For lymphomatous meningitis: 50 mg every 2 wk for 5 doses, then every 4 wk for 5 doses.
Induction and maintenance of remission in acute leukaemias:
- As monotherapy: 200 mg/m2 daily by continuous IV infusion for 5 days, at intervals of approx 2 wk.
- In combination therapy: 100 mg/m2 bid by rapid IV inj or 100 mg/m2 daily by continuous IV infusion both for 7 days. Maintenance: 1-1.5 mg/kg once or twice wkly via IV or SC.
Side effectsView
Nausea, vomiting, fever, rash, diarrhoea, anorexia, oral and anal inflammation or ulceration, hepatic dysfunction, headache, weakness, confusion, thrombocytopenia, fatigue.
ContraindicationsView
Patient with active meningeal infection.
PrecautionsView
Patient with previous drug-induced bone marrow suppression. Renal or hepatic impairment. Pregnancy and lactation.
InteractionsView
May reduce efficacy of 5-fluorocytosine, digoxin, gentamicin. May increase risk of neurotoxicity with other cytotoxic agents (intrathecal).
Pregnancy & lactationView
Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Overdose effectsView
Symptoms: Irreversible CNS toxicity and death. Severe arachnoiditis including encephalopathy.
Management: Therapy cessation followed by treatment of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics. Maintain vital functions.
Management: Therapy cessation followed by treatment of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics. Maintain vital functions.
ReconstitutionView
Intravenous: Reconstitute with bacteriostatic water for inj (standard-dose), further dilute in 250-1,000 ml NaCl 0.9% or dextrose 5% in water for infusion.
Intrathecal: Reconstitute with preservative free NaCl 0.9%, further dilute with Elliot’s B soln, NaCl 0.9% or lactated Ringer’s inj to preferred final vol (up to 12 ml).
Intrathecal: Reconstitute with preservative free NaCl 0.9%, further dilute with Elliot’s B soln, NaCl 0.9% or lactated Ringer’s inj to preferred final vol (up to 12 ml).
StorageView
IV/SC: Store between 15-25°C. Intrathecal: Store between 2-8°C. Avoid freezing.
Cytabin
Cytarabine
Cytabin
Cytarabine
Indications
Non-Hodgkin lymphoma
Indication detailsView
Cytarabine is indicated in Leukaemic meningitis, Induction and maintenance of remission in acute leukaemias
Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Cytarabine inhibits deoxyribonucleic acid (DNA) synthesis specifically at the S-phase of the cell cycle. It also has an antiviral and immunosuppressant activity.
DosageView
Intrathecal (Adult)-
Induction and maintenance of remission in acute leukaemias:
- Leukaemic meningitis: 5-75 mg/m2 or 30-100 mg once every 2-7 days to once daily for 4 or 5 days.
- For lymphomatous meningitis: 50 mg every 2 wk for 5 doses, then every 4 wk for 5 doses.
Induction and maintenance of remission in acute leukaemias:
- As monotherapy: 200 mg/m2 daily by continuous IV infusion for 5 days, at intervals of approx 2 wk.
- In combination therapy: 100 mg/m2 bid by rapid IV inj or 100 mg/m2 daily by continuous IV infusion both for 7 days. Maintenance: 1-1.5 mg/kg once or twice wkly via IV or SC.
Side effectsView
Nausea, vomiting, fever, rash, diarrhoea, anorexia, oral and anal inflammation or ulceration, hepatic dysfunction, headache, weakness, confusion, thrombocytopenia, fatigue.
ContraindicationsView
Patient with active meningeal infection.
PrecautionsView
Patient with previous drug-induced bone marrow suppression. Renal or hepatic impairment. Pregnancy and lactation.
InteractionsView
May reduce efficacy of 5-fluorocytosine, digoxin, gentamicin. May increase risk of neurotoxicity with other cytotoxic agents (intrathecal).
Pregnancy & lactationView
Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Overdose effectsView
Symptoms: Irreversible CNS toxicity and death. Severe arachnoiditis including encephalopathy.
Management: Therapy cessation followed by treatment of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics. Maintain vital functions.
Management: Therapy cessation followed by treatment of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics. Maintain vital functions.
ReconstitutionView
Intravenous: Reconstitute with bacteriostatic water for inj (standard-dose), further dilute in 250-1,000 ml NaCl 0.9% or dextrose 5% in water for infusion.
Intrathecal: Reconstitute with preservative free NaCl 0.9%, further dilute with Elliot’s B soln, NaCl 0.9% or lactated Ringer’s inj to preferred final vol (up to 12 ml).
Intrathecal: Reconstitute with preservative free NaCl 0.9%, further dilute with Elliot’s B soln, NaCl 0.9% or lactated Ringer’s inj to preferred final vol (up to 12 ml).
StorageView
IV/SC: Store between 15-25°C. Intrathecal: Store between 2-8°C. Avoid freezing.
Cytapen-V
Phenoxymethyl Penicillin [Penicillin V]
Cytapen-V
Phenoxymethyl Penicillin [Penicillin V]
Indications
Vincent’s infection
Indication detailsView
For the treatment of mild to moderately severe bacterial infections, if these are due to penicillin susceptible pathogens and respond to therapy with oral penicillin, such as:
- infections of the ear, nose and throat regions, e.g., tonsillitis, pharyngitis, laryngitis, otitis media, sinusitis.
- infections of the lower respiratory tract, e.g., bronchitis and pneumonia, bronchopneumonia.
- infections due to beta-hemolytic streptococci of group A, e.g., scarlet fever, erysipelas, rheumatic fever.
- skin infections, e.g., pyodermia, furunculosis, phlegmon, erysipeloid, erythema migrans, insofar as the micro-organisms are penicillin-susceptible.
- lymphadenitis and lymphangitis of bacterial origin.
- infections of the buccal cavity, gums or jaws, e.g., inflammatory infiltrates, delayed dentition stages II and III, antral fistulae, secondary bacterial infection with Gram-positive pathogens following virus-induced gingivitis or stomatitis.
Therapeutic classView
Benzylpenicillin & Phenoxymethyl penicillin
PharmacologyView
Phenoxymethyl penicillin or penicillin V is acid-stable and is absorbed from the upper part of the small intestine. Of different forms of Phenoxymethyl penicillin, the potassium salt of Phenoxymethyl penicillin is best absorbed. This may be given with meals but maximum absorption is achieved when drug is administered orally at least 1 hour before or 2 hours after the meal. Phenoxymethyl penicillin offers a very convenient means of treating Grampositive infections. Phenoxymethyl penicillin has the distinct advantage over penicillin G in resistance to inactivation by gastric acid.
DosageView
The dosage of Phenoxymethyl penicillin should be determined according to the sensitivity of the causative micro-organism and the severity of the infection, and adjusted to the clinical response of the patient.
Adults: 250-500 mg 6 hourly
Children (above 1 year):
Adults: 250-500 mg 6 hourly
Children (above 1 year):
- 125-250 mg 6 hourly
- 125 mg/5 ml powder for suspension: 1-2 teaspoonful (5-10 ml) 6 hourly
- 250 mg/5 ml powder for suspension: ½-1 teaspoonful (2.5-5 ml) 6 hourly
- 62.5-125 mg 6 hourly.
- 125 mg/5 ml powder for suspension: ½-1 teaspoonful (2.5-5 ml) 6 hourly, or as prescribed by the physician.
AdministrationView
Phenoxymethyl Penicillin is best taken on an empty stomach, preferably one hour before meals. The tablets are swallowed without chewing with sufficient amounts of liquid. Before each use of this syrup, the bottle has to be shaken vigorously.
Side effectsView
Occasionally, hypersensitivity reactions involving the skin (e.g. urticaria, morbilliform or scarlatiniform rashes, pruritus), eosinophilia or more serious allergic reactions, e.g. drug fever, vasculitis, serum sickness or interstitial nephritis, may develop. Anaphylactic or anaphylactoid reactions accompanied by, e.g- angioneurotic oedema, oedema of the larynx, bronchial spasm and shock may occur.
In the event of signs pointing to anaphylactic/anaphylactoid reactions, the treatment must be terminated immediately. In occasional instances, there may be skin rashes or inflammation of mucous membranes, especially in the region of the mouth (stomatitis); dryness of the mouth and disorders of taste may rarely occur.
The occurrence of severe bullous skin reactions- usually involving the mucosae- has been reported in isolated cases (Stevens-Johnson syndrome, Lyell's syndrome). Gastrointestinal disturbances with, e.g., nausea, vomiting, abdominal pain, loose stools, or diarrhoea may develop.
Diarrhoea may sometimes be a symptom of enterocolitis which may, in some cases, be haemorrhagic. A particular form of enterocolitis that can occur with antibiotics is pseudomembranous colitis (in most cases due to Clostridium diffcile). This must be considered in patients in whom severe, persistent diarrhoea occurs during treatment or in the initial weeks thereafter. Even if pseudomembranous colitis is only suspected, administration of Phenoxymethyl penicillin must be halted immediately. This type of colitis requires immediate and appropriate treatment by a physician. Drugs that inhibit intestinal peristalsis must not be taken in such cases. In isolated cases, particularly after high doses and prolonged administration, changes in blood picture such as reduction in the number of white blood cells (e.g.,leucopenia, granulocytopenia, agranulocytosis), erythrocytes (e.g., due to haemolytic anaemia), thrombocytes, or pancytopenia and myelosuppression may occur. During treatment for spirochaetal infections, Herxheimer's reaction characterized by the occurrence or worsening of general symptoms such as fever, chills, headache, and joint pains may develop. In isolated cases, drug-induced aseptic meningitis may occur.
In extremely rare cases, transient discolouration of the teeth may be seen during treatment with Phenoxymethyl penicillin. Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro organisms.
Beta-lactams predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.
In the event of signs pointing to anaphylactic/anaphylactoid reactions, the treatment must be terminated immediately. In occasional instances, there may be skin rashes or inflammation of mucous membranes, especially in the region of the mouth (stomatitis); dryness of the mouth and disorders of taste may rarely occur.
The occurrence of severe bullous skin reactions- usually involving the mucosae- has been reported in isolated cases (Stevens-Johnson syndrome, Lyell's syndrome). Gastrointestinal disturbances with, e.g., nausea, vomiting, abdominal pain, loose stools, or diarrhoea may develop.
Diarrhoea may sometimes be a symptom of enterocolitis which may, in some cases, be haemorrhagic. A particular form of enterocolitis that can occur with antibiotics is pseudomembranous colitis (in most cases due to Clostridium diffcile). This must be considered in patients in whom severe, persistent diarrhoea occurs during treatment or in the initial weeks thereafter. Even if pseudomembranous colitis is only suspected, administration of Phenoxymethyl penicillin must be halted immediately. This type of colitis requires immediate and appropriate treatment by a physician. Drugs that inhibit intestinal peristalsis must not be taken in such cases. In isolated cases, particularly after high doses and prolonged administration, changes in blood picture such as reduction in the number of white blood cells (e.g.,leucopenia, granulocytopenia, agranulocytosis), erythrocytes (e.g., due to haemolytic anaemia), thrombocytes, or pancytopenia and myelosuppression may occur. During treatment for spirochaetal infections, Herxheimer's reaction characterized by the occurrence or worsening of general symptoms such as fever, chills, headache, and joint pains may develop. In isolated cases, drug-induced aseptic meningitis may occur.
In extremely rare cases, transient discolouration of the teeth may be seen during treatment with Phenoxymethyl penicillin. Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro organisms.
Beta-lactams predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.
ContraindicationsView
Phenoxymethyl Penicillin must not be administered in patients with hypersensitivity to penicillins or any of the excipients of this. Phenoxymethyl Penicillin must not be used to treat patients with severe gastrointestinal disorders accompanied by vomiting and diarrhea.
PrecautionsView
The possibility of cross-allergy between cephalosporins and penicillins must be considered. When treating patients with heart diseases or serious electrolyte disturbances of other origin, the potassium content of Phenoxymethyl Penicillin may have to be considered. Beta-lactams predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.
Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro-organisms. The patient's condition must therefore be checked at regular intervals. If a secondary infection occurs, appropriate measures must be taken. In patients with diabetes mellitus, the sugar content of Phenoxymethyl Penicillin syrup must be taken into consideration.
There is no indication of impaired ability to drive, or to operate machinery. Beta-lactams predispose the patient to encephalopathy risk. In the case of adverse reactions such as encephalopathy (which may include convulsions, confusion, impairment of consciousness, movement disorders), the patient should not operate machines or drive a vehicle.
Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro-organisms. The patient's condition must therefore be checked at regular intervals. If a secondary infection occurs, appropriate measures must be taken. In patients with diabetes mellitus, the sugar content of Phenoxymethyl Penicillin syrup must be taken into consideration.
There is no indication of impaired ability to drive, or to operate machinery. Beta-lactams predispose the patient to encephalopathy risk. In the case of adverse reactions such as encephalopathy (which may include convulsions, confusion, impairment of consciousness, movement disorders), the patient should not operate machines or drive a vehicle.
InteractionsView
Food: Concurrent intake of food leads to a reduction in the rate of absorption. Therefore, Phenoxymethyl penicillin is best taken on an empty stomach, preferably one hour before meals, in order to reach the highest possible rate of absorption.
Drug interactions: Concomitant administration of penicillins may lead to increased levels of methotrexate in serum and potentiate its toxic effects. Monitoring of methotrexate serum levels is therefore necessary.
If diarrhoea occurs as a consequence of treatment with Phenoxymethyl penicillin, the absorption of other orally administered drugs may be disturbed and their effcacy may consequently be impaired. If penicillins are combined with bacteriostatic chemotherapeutics or antibiotics (e.g., tetracyclines, chloramphenicol), the activity of penicillins may be attenuated or abolished. Concurrent administration of probenecid inhibits the renal excretion of penicillins. Concurrent use of indomethacin, phenylbutazone, salicylates or sulfinpyrazone may cause elevated and prolonged serum levels of phenoxymethylpenicillin.
Administration of penicillins may cause a transient reduction in plasma concentrations of oestrogens and gestagens. The effectiveness of oral contraceptives is therefore uncertain.
The absorption of Phenoxymethyl penicillin may be reduced where intestinal sterilization with aminoglycosides (e.g. neomycin) has just been performed or is still in progress. Combined use of penicillins and oral anticoagulants (e.g. warfarin) may prolong prothrombin time/INR.
Interference with laboratory and diagnostic tests: Non-enzymatic urine glucose determinations and tests for urobilinogen may give false-positive results.
Drug interactions: Concomitant administration of penicillins may lead to increased levels of methotrexate in serum and potentiate its toxic effects. Monitoring of methotrexate serum levels is therefore necessary.
If diarrhoea occurs as a consequence of treatment with Phenoxymethyl penicillin, the absorption of other orally administered drugs may be disturbed and their effcacy may consequently be impaired. If penicillins are combined with bacteriostatic chemotherapeutics or antibiotics (e.g., tetracyclines, chloramphenicol), the activity of penicillins may be attenuated or abolished. Concurrent administration of probenecid inhibits the renal excretion of penicillins. Concurrent use of indomethacin, phenylbutazone, salicylates or sulfinpyrazone may cause elevated and prolonged serum levels of phenoxymethylpenicillin.
Administration of penicillins may cause a transient reduction in plasma concentrations of oestrogens and gestagens. The effectiveness of oral contraceptives is therefore uncertain.
The absorption of Phenoxymethyl penicillin may be reduced where intestinal sterilization with aminoglycosides (e.g. neomycin) has just been performed or is still in progress. Combined use of penicillins and oral anticoagulants (e.g. warfarin) may prolong prothrombin time/INR.
Interference with laboratory and diagnostic tests: Non-enzymatic urine glucose determinations and tests for urobilinogen may give false-positive results.
Pregnancy & lactationView
Phenoxymethylpenicillin crosses the placenta. Given the appropriate indication, this may be used at any time throughout pregnancy. Phenoxymethylpenicillin passes into the breast milk in small amounts. This may be used during lactation; however, diarrhoea and yeast colonization of mucous membranes may occur in the infant.
Overdose effectsView
The toxicity of phenoxymethylpenicillin is low, and it has a broad therapeutic range. When a multiple therapeutic dose is taken orally once only, phenoxymethylpenicillin has no acute toxicity. There is a risk of encephalopathy in cases of administration of beta-lactam antibiotics, particularly in case of overdose or renal impairment. Special measures in the event of overdosage, other than discontinuation of the medication, are not required. Elimination of phenoxymethylpenicillin can be accomplished through haemodialysis.
StorageView
Store in a cool and dry place, protect from light.