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Fibolac

Lactitol Monohydrate

Oral Powder 10 gm/sachet Allopathic Osmotic purgatives

Indications

Hepatic encephalopathy

Indication detailsView

Lactitol Monohydrate is indicated in chronic idiopathic constipation (CIC), acute and chronic portal systemic encephalopathy.

Therapeutic classView

Osmotic purgatives

PharmacologyView

Lactitol Monohydrate is a disaccharide derivatives consisting of galactose and sorbitol, which is only minimally absorbed and is not hydrolysed by the disaccharidases of the GIT and thus reaches the colon unchanged. In the colon it is broken down to short chain low molecular weight organic acids by the intestinal flora, resulting in an increase in osmotic pressure in the colon, thereby causing an increase in the stool water content and stool volume, which explains the laxative effect. Lactitol Monohydrate produces its effect in the lumen of the colon, where it is virtually 100% bioavailable. It is absorbed only in minimal amounts. Up to 2% can be found unchanged in the urine.

DosageView

Lactitol can be mixed with hot or cold beverages, puddings etc. Dosage will require adjustment to obtaine one daily bowel movement in constipated patients and two daily bowel movements in patients with portal systemic encephalopathy.

In constipation: In adult: The initial daily dosage should be 20 g taken in a single dose with the morning or evening meal. After a few days, a daily dose of 10 g may be sufficient.

Children: The mean dosage is 0.25 g/kg body weight daily.

1 to 6 years: 2.5 to 5 gm
6 to 12 years: 5 to 10 gm
12 to 16 years: 10 to 20 gm

The effect of lactitol has been found mostly to occur within a few hours after intake. But in some cases the first laxative response may be delayed until the second or third day of administration. Therefore patients should be advised to maintain an adequate daily fluid intake.

In portal systemic encephalopathy: The dose should be adjusted according to the severity of the patient’s disease and their individual response. The initial recommended dose is 0.5 to 0.7 gm/kg body weight daily, divided into three daily doses with meals.

Side effectsView

At the start of the treatment with lactitol may produce abdominal discomforts such as flatulence, pain, cramps or sensation of fullness. Such effects tend to diminish or disappear after a few days of regular intake of Lactitol. Occasionally, nausea or anal pruritus has been reported in some cases.

ContraindicationsView

Patients with known hypersensitivity to any of the ingredients of this preparation.

PrecautionsView

Elderly or debilitated patients receiving long-term treatment with lactitol should have their serum electrolytes monitored regularly.
As for all laxatives, pre-existing fluid or electrolyte imbalance should be corrected before starting treatment with lactitol.
Following treatment of Lactitol, hydrogen may accumulate in the bowel. Patients who need to undergo electrocauterisation procedure should therefore have a thorough bowel cleansing with a non-fermentable solution.
Lactitol is not recommended in case s of ileostomy or colostomy.
Prolonged use of laxatives without interruption should be avoided.

InteractionsView

Antacids and neomycin should not be given simultaneously with Lactitol to cirrhotic patients with portal systemic encephalopathy. Lactitol may increase potassium loss caused by other drugs e.g. thiazide diuretics, corticosteroids, carbenoxolone, amphotericin B and it may enhance the risk of toxic effects of glycosides in patients receiving concomitant therapy.

Pregnancy & lactationView

Lactitol is minimally absorbed systemically following oral administration, and it is unknown whether maternal use will result in fetal exposure to the drug. There are no data on the presence of lactitol in human or animal milk, the effects on the breastfed infant, or the effects on milk production.

StorageView

Store in a cool, dry place and away from light. Keep out of reach of children.

Fibosyl

Ispaghula [Psyllium] Husk

Effervescent Powder 3.5 gm/5.4 gm Allopathic Bulk-forming laxatives

Indications

Constipation

Indication detailsView

Psyllium Husk is indicated in-

Constipation
Raised levels of cholesterol
Hemorrhoids or piles
Irritable bowel syndrome (IBS)
Reduces blood glucose level

Psyllium also provides easy bowel movement with smooth stool. So, it is desirable in patients with anal fissures, colon cancer, post anal & rectal surgery and during pregnancy.

Therapeutic classView

Bulk-forming laxatives

DosageView

Usual dose: 1 spoonful 1-3 times daily or as per doctor's advice.

Adults and children over 12 years: 1 spoonful with water 2 times daily or as per doctor's advice.

Children 6 to 12 years: ½ to 1 spoonful with water depending on age and size, in the morning and at bedtime or as per doctor's advice.

Children below 6 years: Not recommended except as directed by the physician.

An additional glass of water is helpful after taking this gel.

AdministrationView

Take one spoonful with the provided spoon.
Put this husk into an empty glass.
Fill glass with water (150 ml or 2/3 of the glass) stir & drink immediately.

Side effectsView

Common side effects are flatulence, abdominal distension, gastro-intestinal obstruction.

ContraindicationsView

Contraindicated in patients with gastrointestinal tract obstruction or threatening obstruction of the bowel.

InteractionsView

No significant interaction has been observed with other medicine.

StorageView

Store in a cool and dry place. Keep out of reach of children.

Fibosyl

Ispaghula [Psyllium] Husk

Effervescent Powder 3.5 gm/sachet Allopathic Bulk-forming laxatives

Indications

Constipation

Indication detailsView

Psyllium Husk is indicated in-

Constipation
Raised levels of cholesterol
Hemorrhoids or piles
Irritable bowel syndrome (IBS)
Reduces blood glucose level

Psyllium also provides easy bowel movement with smooth stool. So, it is desirable in patients with anal fissures, colon cancer, post anal & rectal surgery and during pregnancy.

Therapeutic classView

Bulk-forming laxatives

DosageView

Usual dose: 1 spoonful 1-3 times daily or as per doctor's advice.

Adults and children over 12 years: 1 spoonful with water 2 times daily or as per doctor's advice.

Children 6 to 12 years: ½ to 1 spoonful with water depending on age and size, in the morning and at bedtime or as per doctor's advice.

Children below 6 years: Not recommended except as directed by the physician.

An additional glass of water is helpful after taking this gel.

AdministrationView

Take one spoonful with the provided spoon.
Put this husk into an empty glass.
Fill glass with water (150 ml or 2/3 of the glass) stir & drink immediately.

Side effectsView

Common side effects are flatulence, abdominal distension, gastro-intestinal obstruction.

ContraindicationsView

Contraindicated in patients with gastrointestinal tract obstruction or threatening obstruction of the bowel.

InteractionsView

No significant interaction has been observed with other medicine.

StorageView

Store in a cool and dry place. Keep out of reach of children.

Fibre

Fenofibrate

Capsule 200 mg Allopathic Fibrates

Indications

Hypertriglyceridaemia

Indication detailsView

Fenofibrate is indicated for hyperlipidemias of type lla, llb, III, IV & V in patients who have not responded adequately to diet & other appropriate measures.

Therapeutic classView

Fibrates

PharmacologyView

Fenofibrate is a fibric acid derivative. Fenofibrate is rapidly hydrolyzed after oral ingestion to its pharmacologically active form, fenofibric acid. Fenofibric acid produces reductions in total cholesterol, LDL cholesterol, Apo-lipoprotein B, Total triglycerides and VLDL. In addition, treatment with Fenofibrate results in increases in HDL and apo-proteins apoAI apoAII. Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid. The micronised form of Nofiate (Fenofibrate) has enhanced absorption over the non-micronised formulation.

DosageView

For the treatment of adult patients with hypercholesterolemia or mixed hyperlipidemia, the initial dose of Fenofibrate is 200 mg per day.
For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day.
Dose should be individualized according to patient response. Fenofibrate should be given with meal there by, optimizing the bioavailability of the medication. Or, as directed by the registered physician.

Side effectsView

Gastro-intestinal (e.g. nausea, anorexia, gastric pain), pruritus, urticaria, impotence, also headache, dizziness, vertigo, fatigue, hair loss; myotoxicity.

ContraindicationsView

Fenofibrate is contraindicated in patients with hypersensitivity to Fenofibrate, severe renal or hepatic impairment, existing gall bladder disease, breast feeding mothers, photosensitivity to ketoprofen.

PrecautionsView

Special care needed in patients with renal disease, as progressive increases in serum creatinine concentration or failure to follow dosage guidelines may result in myotoxicity; discontinue if myotoxicity suspected or creatinine kinase concentration increases significantly. Liver function tests recommended every 3 months for first year.

InteractionsView

Fenofibrate has been reported to potentiate the anticoagulant effects of warfarin. When administered with antidiabetic drug it may improve glucose tolerance and have additive effect. Fenofibrate may also increase the nephrotoxicity of cyclosporine. Due to a potential increase in the risk of rhabdomyolysis, cautions should be taken against the use of Fenofibrate with HMG-CoA reductase inhibitors. However, the use of low-dose statins with Fenofibrate appears to be well tolerated.

Pregnancy & lactationView

Fenofibrate is not recommended for pregnant women.

Overdose effectsView

There is no specific treatment for overdose with Fenofibrate. General supportive care of the patients is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. Because Fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.

StorageView

Do not store above 30°C. Keep away from light and out of the reach of children.

Fibrino

Tranexamic Acid

IM/IV Injection 500 mg/5 ml Allopathic Anti-fibrinolytic drugs

Indications

Uterine bleeding

Indication detailsView

In medicine: Prophylaxis and therapy of hemophtoes, digestive hemorrhages, hemorrhagic syndromes in leukaemia, cirrhosis and hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy and transfusion.

In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.

In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.

In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.

In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.

In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.

In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.

Therapeutic classView

Anti-fibrinolytic drugs, Haemostatic drugs

PharmacologyView

This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.

The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.

Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.

DosageView

Adults-

The usual dose: 500-1000 mg 3 times daily.
For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.

Children-

For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.

Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.

Side effectsView

Tranexamic Acid is generally well tolerated; there may be infrequent cases of sense of fatigue, conjunctival irritation, nasal blockage, itching, skin reddening, exanthems.
After oral administration there may be sign of nausea, diarrhea, gastric pyrosis.
There are rare cases of postural hypotension.
In the case of hypersensitivity to tranexamic acid, avoid or suspend treatment and start a suitable therapy.

ContraindicationsView

Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.

PrecautionsView

Tranexamic Acid should be used in cases where there is hyperfibrinolysis. The prophylactic treatment must begin 24 hours before the operation and continue until 3-4 days after it.
The therapy of hemorrhages must be prolonged for at least 24 hours after manifestations have disappeared.
In hematuria, especially when this is not accompanied by any other hemorrhagic manifestations, reduce the doses to prevent formation of clots in the urinary tract.
Tranexamic Acid must not be used in serious renal insufficiency or anuric syndromes and must only be used with caution in less serious renal dysfunctions.
The administration of product requires particular care in cardiopathic and hepatopathic subjects.

InteractionsView

Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.

Pregnancy & lactationView

Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

StorageView

Store in a dry place at 15-30°C, away from light and keep out of children's reach.

Fibrino

Tranexamic Acid

Capsule 500 mg Allopathic Anti-fibrinolytic drugs

Indications

Uterine bleeding

Indication detailsView

In medicine: Prophylaxis and therapy of hemophtoes, digestive hemorrhages, hemorrhagic syndromes in leukaemia, cirrhosis and hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy and transfusion.

In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.

In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.

In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.

In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.

In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.

In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.

Therapeutic classView

Anti-fibrinolytic drugs, Haemostatic drugs

PharmacologyView

This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.

The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.

Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.

DosageView

Adults-

The usual dose: 500-1000 mg 3 times daily.
For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.

Children-

For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.

Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.

Side effectsView

Tranexamic Acid is generally well tolerated; there may be infrequent cases of sense of fatigue, conjunctival irritation, nasal blockage, itching, skin reddening, exanthems.
After oral administration there may be sign of nausea, diarrhea, gastric pyrosis.
There are rare cases of postural hypotension.
In the case of hypersensitivity to tranexamic acid, avoid or suspend treatment and start a suitable therapy.

ContraindicationsView

Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.

PrecautionsView

Tranexamic Acid should be used in cases where there is hyperfibrinolysis. The prophylactic treatment must begin 24 hours before the operation and continue until 3-4 days after it.
The therapy of hemorrhages must be prolonged for at least 24 hours after manifestations have disappeared.
In hematuria, especially when this is not accompanied by any other hemorrhagic manifestations, reduce the doses to prevent formation of clots in the urinary tract.
Tranexamic Acid must not be used in serious renal insufficiency or anuric syndromes and must only be used with caution in less serious renal dysfunctions.
The administration of product requires particular care in cardiopathic and hepatopathic subjects.

InteractionsView

Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.

Pregnancy & lactationView

Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

StorageView

Store in a dry place at 15-30°C, away from light and keep out of children's reach.

Fibropress

Ulipristal Acetate [For uterine fibroids]

Tablet 5 mg Allopathic Drugs acting on the Uterus

Indications

Uterine fibroids

Indication detailsView

Ulipristal Acetate is used before surgery to treat moderate to severe symptoms of uterine fibroids, which are noncancerous (benign) tumors of the womb (uterus). Ulipristal Acetate is used in adult women who have not yet reached menopause.

Therapeutic classView

Drugs acting on the Uterus

PharmacologyView

Ulipristal acetate is a selective progesterone receptor modulator. It acts by blocking the receptor of a hormone in the body called progesterone, which is involved in controlling the growth of the lining of the womb. In some women, progesterone may promote the growth of fibroids, which may cause symptoms such as heavy uterine bleeding, anaemia and abdominal pain. When progesterone activity is blocked, fibroid cells stop dividing and eventually die which reduces the size of the fibroids and reduces the symptoms caused by them.

DosageView

Ulipristal acetate is taken by mouth and the recommended dose is one tablet (5 mg) a day for up to three months. The three month treatment can be repeated but only once. Treatment should always be started during the first week of the menstrual cycle (period bleeding).

Side effectsView

Common side effects are Endometrial thickening, Hot flush, Headache, Uterine haemorrhage

ContraindicationsView

Contraindicated in patients with-

Hypersensitivity to the active substance or to any of the excipients.
Pregnancy and breastfeeding.
Genital bleeding of unknown aetiology or for reasons other than uterine fibroids.
Uterine, cervical, ovarian or breast cancer.

PrecautionsView

Ulipristal acetate should only be prescribed after careful diagnosis and Pregnancy should be precluded prior to treatment.

Contraception: Concomitant use of progestagen-only pills, a progestagen releasing intrauterine device or combined oral contraceptive pills is not recommended. Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non-hormonal contraceptive method is recommended during treatment.
Endometrial Changes: Endometrial Thickening or Progesterone receptor modulator Associated Endometrial Changes (PAEC). Ulipristal acetate has a specific pharmacodynamic action on the endometrium. An increase in thickness of the endometrium may occur. The thickness of the endometrium decreases to baseline levels upon treatment cessation. If the endometrial thickening persists beyond 3 months following the end of treatment and return of menstruations, this may need to be investigated as per usual clinical practice to exclude underlying conditions.
Bleeding Pattern: Patients should be informed that treatment with ulipristal acetate usually leads to a significant reduction in menstrual blood loss or amenorrhea within the first 10 days of treatment. Should the excessive bleeding persist, patients should notify their physician.
Asthma Patients: Use in women with severe asthma insufficiently controlled by oral glucocorticoids is not recommended.

Pregnancy & lactationView

Pregnancy Category X. Ulipristal acetate is contraindicated during pregnancy. Ulipristal acetate is excreted in human milk and is not recommended.

Pediatric usageView

Hepatic Impairment: Ulipristal acetate is not recommended in patients with severe hepatic impairment unless the patient is closely monitored.

Renal Impairment: Renal impairment is not expected to significantly alter the elimination of ulipristal acetate. In the absence of specific studies, ulipristal acetate is not recommended for patients with moderate and severe renal impairment unless the patient is closely monitored.

Overdose effectsView

Experience with ulipristal acetate overdose is limited. Single doses up to 200 mg and daily doses of 50 mg for 10 consecutive days were administered to a limited number of subjects, and no severe or serious adverse reactions were reported.

StorageView

Keep protected from light & moisture, store below 25° C. Keep out of reach of children.

Fibrostat

Tranexamic Acid

Capsule 500 mg Allopathic Anti-fibrinolytic drugs

Indications

Uterine bleeding

Indication detailsView

In medicine: Prophylaxis and therapy of hemophtoes, digestive hemorrhages, hemorrhagic syndromes in leukaemia, cirrhosis and hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy and transfusion.

In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.

In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.

In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.

In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.

In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.

In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.

Therapeutic classView

Anti-fibrinolytic drugs, Haemostatic drugs

PharmacologyView

This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.

The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.

Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.

DosageView

Adults-

The usual dose: 500-1000 mg 3 times daily.
For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.

Children-

For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.

Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.

Side effectsView

Tranexamic Acid is generally well tolerated; there may be infrequent cases of sense of fatigue, conjunctival irritation, nasal blockage, itching, skin reddening, exanthems.
After oral administration there may be sign of nausea, diarrhea, gastric pyrosis.
There are rare cases of postural hypotension.
In the case of hypersensitivity to tranexamic acid, avoid or suspend treatment and start a suitable therapy.

ContraindicationsView

Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.

PrecautionsView

Tranexamic Acid should be used in cases where there is hyperfibrinolysis. The prophylactic treatment must begin 24 hours before the operation and continue until 3-4 days after it.
The therapy of hemorrhages must be prolonged for at least 24 hours after manifestations have disappeared.
In hematuria, especially when this is not accompanied by any other hemorrhagic manifestations, reduce the doses to prevent formation of clots in the urinary tract.
Tranexamic Acid must not be used in serious renal insufficiency or anuric syndromes and must only be used with caution in less serious renal dysfunctions.
The administration of product requires particular care in cardiopathic and hepatopathic subjects.

InteractionsView

Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.

Pregnancy & lactationView

Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

StorageView

Store in a dry place at 15-30°C, away from light and keep out of children's reach.

Fibrostat

Tranexamic Acid

IM/IV Injection 500 mg/5 ml Allopathic Anti-fibrinolytic drugs

Indications

Uterine bleeding

Indication detailsView

In medicine: Prophylaxis and therapy of hemophtoes, digestive hemorrhages, hemorrhagic syndromes in leukaemia, cirrhosis and hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy and transfusion.

In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.

In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.

In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.

In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.

In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.

In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.

Therapeutic classView

Anti-fibrinolytic drugs, Haemostatic drugs

PharmacologyView

This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.

The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.

Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.

DosageView

Adults-

The usual dose: 500-1000 mg 3 times daily.
For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.

Children-

For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.

Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.

Side effectsView

Tranexamic Acid is generally well tolerated; there may be infrequent cases of sense of fatigue, conjunctival irritation, nasal blockage, itching, skin reddening, exanthems.
After oral administration there may be sign of nausea, diarrhea, gastric pyrosis.
There are rare cases of postural hypotension.
In the case of hypersensitivity to tranexamic acid, avoid or suspend treatment and start a suitable therapy.

ContraindicationsView

Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.

PrecautionsView

Tranexamic Acid should be used in cases where there is hyperfibrinolysis. The prophylactic treatment must begin 24 hours before the operation and continue until 3-4 days after it.
The therapy of hemorrhages must be prolonged for at least 24 hours after manifestations have disappeared.
In hematuria, especially when this is not accompanied by any other hemorrhagic manifestations, reduce the doses to prevent formation of clots in the urinary tract.
Tranexamic Acid must not be used in serious renal insufficiency or anuric syndromes and must only be used with caution in less serious renal dysfunctions.
The administration of product requires particular care in cardiopathic and hepatopathic subjects.

InteractionsView

Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.

Pregnancy & lactationView

Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

StorageView

Store in a dry place at 15-30°C, away from light and keep out of children's reach.

Fibroz

Nintedanib

Capsule 150 mg Allopathic Tyrosine Kinase Inhibitor

Indications

Idiopathic Pulmonary Fibrosis

Indication detailsView

Nintedanib is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
Nintedanib is indicated in adults for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.
Nintedanib is indicated in adults for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Nintedanib is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology after first-line chemotherapy.

Therapeutic classView

Tyrosine Kinase Inhibitor

PharmacologyView

Nintedanib is a small molecule, competitive, triple angiokinase inhibitor that targets multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Many of these RTKs are implicated in lung fibrosis and tumour angiogenesis, so nintedanib is therefore used in the treatment of proliferative diseases such as idiopathic pulmonary fibrosis, non-small cell lung cancer, and systemic sclerosis-associated interstitial lung disease. The specific RTKs that nintedanib inhibits are platelet-derived growth factor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, vascular endothelial growth factor receptor (VEGFR), and Fns-Like tyrosine kinase-3 (FLT3). Nintedanib binds to the ATP-binding pocket of these receptors and inhibits their activity, thereby blocking signalling cascades that result in the proliferation and migration of lung fibroblasts. Nintedanib also inhibits kinase signalling pathways in various cells within tumour tissues, including endothelial cells, pericytes, smooth muscle cells, and cells contributing to angiogenesis, culminating in an inhibition of cell proliferation and apoptosis of affected tumour cells.

In addition to RTK inhibition, nintedanib also prevents the actions of the nRTKs Lck, Lyn, and Src. The contribution of the inhibition of Lck and Lyn towards the therapeutic efficacy of nintedanib is unclear, but inhibition of the Src pathway by nintedanib has been shown to reduce lung fibrosis.

DosageView

Treatment with Nintedanib should be initiated by physicians experienced in the diagnosis and treatment of IPF.

Posology: The recommended dose is 150 mg Nintedanib twice daily administered approximately 12 hours apart. The 100 mg twice daily dose is only recommended to be used in patients who do not tolerate the 150 mg twice daily dose. If a dose is missed, administration should resume at the next scheduled time at the recommended dose. If a dose is missed the patient should not take an additional dose. The recommended maximum daily dose of 300 mg should not be exceeded.

For NSCLC:

The recommended dose of nintedanib is 200 mg twice daily administered approximately 12 hours apart, on days 2 to 21 of a standard 21 day docetaxel treatment cycle.
Nintedanib must not be taken on the same day of docetaxel chemotherapy administration (= day 1). If a dose of nintedanib is missed, administration should resume at the next scheduled time at the recommended dose. The individual daily doses of nintedanib should not be increased beyond the recommended dose to make up for missed doses. The recommended maximum daily dose of 400 mg should not be exceeded.
Patients may continue therapy with nintedanib after discontinuation of docetaxel for as long as clinical benefit is observed or until unacceptable toxicity occurs.
Dose adjustments: In addition to symptomatic treatment if applicable, the management of adverse reactions to Nintedanib could include dose reduction and temporary interruption until the specific adverse reaction has resolved to levels that allow continuation of therapy. Nintedanib treatment may be resumed at the full dose (150 mg twice daily) or a reduced dose (100 mg twice daily). If a patient does not tolerate 100 mg twice daily, treatment with Nintedanib should be discontinued.
In case of interruptions due to aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations > 3x upper limit of normal (ULN), once transaminases have returned to baseline values, treatment with Nintedanib may be reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose (150 mg twice daily).

AdministrationView

Nintedanib is for oral use. The capsules should be taken with food, swallowed whole with water, and should not be chewed or crushed.

Side effectsView

Summary of the safety profile: Nintedanib has been studied in clinical trials of 1,529 patients suffering from IPF. The safety data provided in the following are based on the two Phase III, randomized, double-blind, placebo-controlled studies in 1,061 patients comparing treatment with Nintedanib 150 mg twice daily to placebo for 52 weeks (INPULSIS-1 and INPULSIS-2) and based on data observed during the post-marketing period.

The most frequently reported adverse reactions associated with the use of Nintedanib included diarrhea, nausea and vomiting, abdominal pain, decreased appetite, weight decreased and hepatic enzyme increased.

Tabulated list of adverse reactions: The below table provides a summary of the adverse reactions by MedDRA System Organ Class (SOC) and frequency category.

Below table summarizes the frequencies of adverse drug reactions (ADRs) that were reported in the Nintedanib group (638 patients) pooled from the two placebo-controlled Phase III clinical trials of 52 weeks duration or from the post-marketing period.

Frequency categories are defined using the following convention: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).

ContraindicationsView

Hypersensitivity to Nintedanib, to peanut or soya, or to any of the excipients.

PrecautionsView

Diarrhoea: In the INPULSIS trials, diarrhoea was the most frequent gastro-intestinal adverse reaction reported in 62.4% versus 18.4% of patients treated with Nintedanib and placebo, respectively. In most patients the adverse reaction was of mild to moderate intensity and occurred within the first 3 months of treatment. Diarrhoea led to dose reduction in 10.7% of the patients and to discontinuation of Nintedanib in 4.4% of the patients in clinical trials. Serious cases of diarrhoea leading to dehydration and electrolyte disturbances have been reported in the post-marketing. Patients should be treated at first signs with adequate hydration and anti-diarrhoeal medicinal products, e.g. loperamide, and may require treatment interruption. Nintedanib treatment may be resumed at a reduced dose (100 mg twice daily) or at the full dose (150 mg twice daily). In case of persisting severe diarrhoea despite symptomatic treatment, therapy with Nintedanib should be discontinued.

Nausea and vomiting: Nausea and vomiting were frequently reported gastrointestinal adverse reactions. In most patients with nausea and vomiting, the event was of mild to moderate intensity. Nausea led to discontinuation of Nintedanib in 2.0% of patients. Vomiting led to discontinuation in 0.8% of the patients. If symptoms persist despite appropriate supportive care (including anti-emetic therapy), dose reduction or treatment interruption may be required. The treatment may be resumed at a reduced dose (100 mg twice daily) or at the full dose (150 mg twice daily). In case of persisting severe symptoms therapy with Nintedanib should be discontinued.

Hepatic function: The safety and efficacy of Nintedanib has not been studied in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Therefore, treatment with Nintedanib is not recommended in such patients. Based on increased exposure, the risk for adverse events may be increased in patients with mild hepatic impairment (Child Pugh A). Patients with mild hepatic impairment (Child Pugh A) should be treated with a reduced dose of Nintedanib. Cases of drug-induced liver injury have been observed with Nintedanib treatment, including severe liver injury with fatal outcome. The majority of hepatic events occur within the first three months of treatment. Therefore, hepatic transaminase and bilirubin levels should be investigated before treatment initiation and during the first month of treatment with Nintedanib. Patients should then be monitored at regular intervals during the subsequent two months of treatment and periodically thereafter, e.g. at each patient visit or as clinically indicated. Elevations of liver enzymes (ALT, AST, ALKP, gamma-glutamyl-transferase (GGT) and bilirubin were reversible upon dose reduction or interruption in the majority of cases. If transaminase (AST or ALT) elevations > 3x ULN are measured, dose reduction or interruption of the therapy with Nintedanib is recommended and the patient should be monitored closely. Once transaminases have returned to baseline values, treatment with Nintedanib may be resumed at the full dose (150 mg twice daily) or reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose. If any liver test elevations are associated with clinical signs or symptoms of liver injury, e.g. jaundice, treatment with Nintedanib should be permanently discontinued. Alternative causes of the liver enzyme elevations should be investigated.

Patients with low body weight (<65 kg), Asian and female patients have a higher risk of elevations of liver enzymes. Nintedanib exposure increased linearly with patient age, which may also result in a higher risk of developing liver enzyme elevations. Close monitoring is recommended in patients with these risk factors.

Renal Function: Cases of renal impairment/failure, in some cases with fatal outcome, have been reported with Nintedanib use. Patients should be monitored during Nintedanib therapy, with particular attention to those patients exhibiting risk factors for renal impairment/failure. In case of renal impairment/failure, therapy adjustment should be considered.

Haemorrhage: Vascular endothelial growth factor receptor (VEGFR) inhibition might be associated with an increased risk of bleeding. In the INPULSIS trials with Nintedanib, the frequency of patients who experienced bleeding AEs was slightly higher in the Nintedanib arm (10.3%) than in the placebo arm (7.8%). Non-serious epistaxis was the most frequent bleeding event. Serious bleeding events occurred with low and similar frequencies in the 2 treatment groups (placebo: 1.4%; Nintedanib: 1.3%). Patients at known risk for bleeding including patients with inherited predisposition to bleeding or patients receiving a full dose of anti-coagulative treatment were not included in the INPULSIS studies. Non-serious and serious bleeding events, some of which were fatal, have been reported in the post-marketing period (including patients with or without anticoagulant therapy or other drugs that could cause bleeding). Therefore, these patients should only be treated with Nintedanib if the anticipated benefit outweighs the potential risk. Post-marketing bleeding events include but are not limited to gastrointestinal, respiratory and central nervous organ systems, with the most frequent being gastrointestinal.

Arterial thromboembolic events: Patients with a recent history of myocardial infarction or stroke were excluded from the INPULSIS trials. Arterial thromboembolic events were infrequently reported: in 0.7% of patients in the placebo and 2.5% in the Nintedanib treated group. While adverse events reflecting ischemic heart disease were balanced between the Nintedanib and placebo groups, a higher percentage of patients experienced myocardial infarctions in the Nintedanib group (1.6%) compared to the placebo group (0.5%). Caution should be used when treating patients at higher cardiovascular risk including known coronary artery disease. Treatment interruption should be considered in patients who develop signs or symptoms of acute myocardial ischemia.

Venous thromboembolism: In the INPULSIS trials no increased risk of venous thromboembolism was observed in Nintedanib treated patients. Due to the mechanism of action of Nintedanib patients might have an increased risk of thromboembolic events.

Gastrointestinal perforations: In the INPULSIS trials, the frequency of patients with perforation was very low in both treatment groups: 0% placebo, 0.3% Nintedanib (involving two patients). Due to the mechanism of action of Nintedanib patients might have an increased risk of gastrointestinal perforation. Cases of gastrointestinal perforations, some of which were fatal, have been reported in the post-marketing period. Particular caution should be exercised when treating patients with previous abdominal surgery, previous history of peptic ulceration, diverticular disease or receiving concomitant corticosteroids or NSAIDs. Nintedanib should only be initiated at least 4 weeks after abdominal surgery. Therapy with Nintedanib should be permanently discontinued in patients who develop gastrointestinal perforation.

Hypertension: Administration of Nintedanib may increase blood pressure. Systemic blood pressure should be measured periodically and as clinically indicated.

Wound healing complication: No increased frequency of impaired wound healing was observed in the INPULSIS trials. Based on the mechanism of action Nintedanib may impair wound healing. No dedicated studies investigating the effect of Nintedanib on wound healing were performed. Treatment with Nintedanib should therefore only be initiated or – in case of perioperative interruption – resumed based on clinical judgement of adequate wound healing.

Co-administration with Pirfenidone: In a dedicated pharmacokinetic study, concomitant treatment of Nintedanib with Pirfenidone was investigated in patients with IPF. Based on these results, there is no evidence of a relevant pharmacokinetic drug-drug interaction between Nintedanib and Pirfenidone when administered in combination. In view of the limited number of patients, this study detected only the most frequent adverse events and showed an increase in gastrointestinal adverse events and a trend toward increased hepatic adverse events. Given the similarity in safety profiles for both medicinal products, additive adverse events, including gastrointestinal and hepatic adverse events, may be expected. The benefit-risk balance of concomitant treatment with Pirfenidone has not been established.

Effect on QT interval: No evidence of QT prolongation was observed for Nintedanib in the clinical trial programme. As some other tyrosine kinase inhibitors are known to exert an effect on QT, caution should be exercised when administered Nintedanib in patients who may develop QTc prolongation.

Allergic reaction: Dietary soya products are known to cause allergic reactions including severe anaphylaxis in persons with soya allergy. Patients with known allergy to peanut protein carry an enhanced risk for severe reactions to soya preparations.

InteractionsView

P-glycoprotein (P-gp): Nintedanib is a substrate of P-gp. Co-administration with the potent P-gp inhibitor ketoconazole increased exposure to Nintedanib 1.61-fold based on AUC and 1.83-fold based on Cmax in a dedicated drug-drug interaction study. In a drug-drug interaction study with the potent P-gp inducer rifampicin, exposure to Nintedanib decreased to 50.3% based on AUC and to 60.3% based on Cmax upon co-administration with rifampicin compared to administration of Nintedanib alone. If co-administered with Nintedanib, potent P-gp inhibitors (e.g. ketoconazole, erythromycin or cyclosporine) may increase exposure to Nintedanib. In such cases, patients should be monitored closely for tolerability of Nintedanib. Management of side effects may require interruption, dose reduction, or discontinuation of therapy with Nintedanib. Potent P-gp inducers (e.g. rifampicin, carbamazepine, phenytoin, and St. John’s Wort) may decrease exposure to Nintedanib. Selection of an alternate concomitant medicinal product with no or minimal P-gp induction potential should be considered.

Cytochrome (CYP)-enzymes: Only a minor extent of the biotransformation of Nintedanib consisted of CYP pathways. Nintedanib and its metabolites, the free acid moiety BIBF 1202 and its glucuronide BIBF 1202 glucuronide, did not inhibit or induce CYP enzymes in preclinical studies. The likelihood of drug-drug interactions with Nintedanib based on CYP metabolism is therefore considered to be low.

Co-administration with other medicinal products: The potential for interactions of Nintedanib with hormonal contraceptives was not explored.

Pregnancy & lactationView

Women of childbearing potential/Contraception: Nintedanib may cause foetalharm in humans. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Nintedanib. They should be advised to use adequate contraception during and at least 3 months after the last dose of Nintedanib. Since the effect of Nintedanib on the metabolism and efficacy of hormonal contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy.

Pregnancy: There is no information on the use of Nintedanib in pregnant women, but pre-clinical studies in animals have shown reproductive toxicity of this active substance. As Nintedanib may cause foetal harm also in humans, it must not be used during pregnancy. Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy with Nintedanib. If the patient becomes pregnant while receiving Nintedanib, she should be apprised of the potential hazard to the foetus. Termination of the treatment with Nintedanib should be considered.

Lactation: There is no information on the excretion of Nintedanib and its metabolites in human milk. Pre-clinical studies showed that small amounts of Nintedanib and its metabolites (≤ 0.5% of the administered dose) were secreted into milk of lactating rats. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with Nintedanib.

Fertility: Based on preclinical investigations there is no evidence for impairment of male fertility. From subchronic and chronic toxicity studies, there is no evidence that female fertility in rats is impaired at a systemic exposure level comparable with that at the maximum recommended human dose (MRHD) of 150 mg twice daily.

Pediatric usageView

Elderly patients (≥65 years): No overall differences in safety and efficacy were observed for elderly patients. No a-priori dose adjustment is required on the basis of a patient’s age. Patients ≥75 years may be more likely to require dose reduction to manage adverse effects.

Renal impairment: Less than 1% of a single dose of Nintedanib is excreted via the kidney. Adjustment of the starting dose in patients with mild to moderate renal impairment is not required. The safety, efficacy, and pharmacokinetics of Nintedanib have not been studied in patients with severe renal impairment (<30 ml/min creatinine clearance).

Hepatic impairment: Nintedanib is predominantly eliminated via biliary/faecal excretion (> 90%). Exposure increased in patients with hepatic impairment (Child Pugh A, Child Pugh B). In patients with mild hepatic impairment (Child Pugh A), the recommended dose of Nintedanib is 100 mg twice daily approximately 12 hours apart. In patients with mild hepatic impairment (Child Pugh A), treatment interruption or discontinuation for management of adverse reactions should be considered. The safety and efficacy of Nintedanib have not been investigated in patients with hepatic impairment classified as Child Pugh B and C. Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Nintedanib is not recommended.

Paediatric population: The safety and efficacy of Nintedanib in children aged 0-18 years have not been established. No data are available.

StorageView

Store in a cool and dry place, protected from light. Do not store above 25°C.

Fibroz

Nintedanib

Capsule 100 mg Allopathic Tyrosine Kinase Inhibitor

Indications

Idiopathic Pulmonary Fibrosis

Indication detailsView

Nintedanib is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
Nintedanib is indicated in adults for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.
Nintedanib is indicated in adults for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Nintedanib is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology after first-line chemotherapy.

Therapeutic classView

Tyrosine Kinase Inhibitor

PharmacologyView

Nintedanib is a small molecule, competitive, triple angiokinase inhibitor that targets multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Many of these RTKs are implicated in lung fibrosis and tumour angiogenesis, so nintedanib is therefore used in the treatment of proliferative diseases such as idiopathic pulmonary fibrosis, non-small cell lung cancer, and systemic sclerosis-associated interstitial lung disease. The specific RTKs that nintedanib inhibits are platelet-derived growth factor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, vascular endothelial growth factor receptor (VEGFR), and Fns-Like tyrosine kinase-3 (FLT3). Nintedanib binds to the ATP-binding pocket of these receptors and inhibits their activity, thereby blocking signalling cascades that result in the proliferation and migration of lung fibroblasts. Nintedanib also inhibits kinase signalling pathways in various cells within tumour tissues, including endothelial cells, pericytes, smooth muscle cells, and cells contributing to angiogenesis, culminating in an inhibition of cell proliferation and apoptosis of affected tumour cells.

In addition to RTK inhibition, nintedanib also prevents the actions of the nRTKs Lck, Lyn, and Src. The contribution of the inhibition of Lck and Lyn towards the therapeutic efficacy of nintedanib is unclear, but inhibition of the Src pathway by nintedanib has been shown to reduce lung fibrosis.

DosageView

Treatment with Nintedanib should be initiated by physicians experienced in the diagnosis and treatment of IPF.

Posology: The recommended dose is 150 mg Nintedanib twice daily administered approximately 12 hours apart. The 100 mg twice daily dose is only recommended to be used in patients who do not tolerate the 150 mg twice daily dose. If a dose is missed, administration should resume at the next scheduled time at the recommended dose. If a dose is missed the patient should not take an additional dose. The recommended maximum daily dose of 300 mg should not be exceeded.

For NSCLC:

The recommended dose of nintedanib is 200 mg twice daily administered approximately 12 hours apart, on days 2 to 21 of a standard 21 day docetaxel treatment cycle.
Nintedanib must not be taken on the same day of docetaxel chemotherapy administration (= day 1). If a dose of nintedanib is missed, administration should resume at the next scheduled time at the recommended dose. The individual daily doses of nintedanib should not be increased beyond the recommended dose to make up for missed doses. The recommended maximum daily dose of 400 mg should not be exceeded.
Patients may continue therapy with nintedanib after discontinuation of docetaxel for as long as clinical benefit is observed or until unacceptable toxicity occurs.
Dose adjustments: In addition to symptomatic treatment if applicable, the management of adverse reactions to Nintedanib could include dose reduction and temporary interruption until the specific adverse reaction has resolved to levels that allow continuation of therapy. Nintedanib treatment may be resumed at the full dose (150 mg twice daily) or a reduced dose (100 mg twice daily). If a patient does not tolerate 100 mg twice daily, treatment with Nintedanib should be discontinued.
In case of interruptions due to aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations > 3x upper limit of normal (ULN), once transaminases have returned to baseline values, treatment with Nintedanib may be reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose (150 mg twice daily).

AdministrationView

Nintedanib is for oral use. The capsules should be taken with food, swallowed whole with water, and should not be chewed or crushed.

Side effectsView

Summary of the safety profile: Nintedanib has been studied in clinical trials of 1,529 patients suffering from IPF. The safety data provided in the following are based on the two Phase III, randomized, double-blind, placebo-controlled studies in 1,061 patients comparing treatment with Nintedanib 150 mg twice daily to placebo for 52 weeks (INPULSIS-1 and INPULSIS-2) and based on data observed during the post-marketing period.

The most frequently reported adverse reactions associated with the use of Nintedanib included diarrhea, nausea and vomiting, abdominal pain, decreased appetite, weight decreased and hepatic enzyme increased.

Tabulated list of adverse reactions: The below table provides a summary of the adverse reactions by MedDRA System Organ Class (SOC) and frequency category.

Below table summarizes the frequencies of adverse drug reactions (ADRs) that were reported in the Nintedanib group (638 patients) pooled from the two placebo-controlled Phase III clinical trials of 52 weeks duration or from the post-marketing period.

Frequency categories are defined using the following convention: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).

ContraindicationsView

Hypersensitivity to Nintedanib, to peanut or soya, or to any of the excipients.

PrecautionsView

Diarrhoea: In the INPULSIS trials, diarrhoea was the most frequent gastro-intestinal adverse reaction reported in 62.4% versus 18.4% of patients treated with Nintedanib and placebo, respectively. In most patients the adverse reaction was of mild to moderate intensity and occurred within the first 3 months of treatment. Diarrhoea led to dose reduction in 10.7% of the patients and to discontinuation of Nintedanib in 4.4% of the patients in clinical trials. Serious cases of diarrhoea leading to dehydration and electrolyte disturbances have been reported in the post-marketing. Patients should be treated at first signs with adequate hydration and anti-diarrhoeal medicinal products, e.g. loperamide, and may require treatment interruption. Nintedanib treatment may be resumed at a reduced dose (100 mg twice daily) or at the full dose (150 mg twice daily). In case of persisting severe diarrhoea despite symptomatic treatment, therapy with Nintedanib should be discontinued.

Nausea and vomiting: Nausea and vomiting were frequently reported gastrointestinal adverse reactions. In most patients with nausea and vomiting, the event was of mild to moderate intensity. Nausea led to discontinuation of Nintedanib in 2.0% of patients. Vomiting led to discontinuation in 0.8% of the patients. If symptoms persist despite appropriate supportive care (including anti-emetic therapy), dose reduction or treatment interruption may be required. The treatment may be resumed at a reduced dose (100 mg twice daily) or at the full dose (150 mg twice daily). In case of persisting severe symptoms therapy with Nintedanib should be discontinued.

Hepatic function: The safety and efficacy of Nintedanib has not been studied in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Therefore, treatment with Nintedanib is not recommended in such patients. Based on increased exposure, the risk for adverse events may be increased in patients with mild hepatic impairment (Child Pugh A). Patients with mild hepatic impairment (Child Pugh A) should be treated with a reduced dose of Nintedanib. Cases of drug-induced liver injury have been observed with Nintedanib treatment, including severe liver injury with fatal outcome. The majority of hepatic events occur within the first three months of treatment. Therefore, hepatic transaminase and bilirubin levels should be investigated before treatment initiation and during the first month of treatment with Nintedanib. Patients should then be monitored at regular intervals during the subsequent two months of treatment and periodically thereafter, e.g. at each patient visit or as clinically indicated. Elevations of liver enzymes (ALT, AST, ALKP, gamma-glutamyl-transferase (GGT) and bilirubin were reversible upon dose reduction or interruption in the majority of cases. If transaminase (AST or ALT) elevations > 3x ULN are measured, dose reduction or interruption of the therapy with Nintedanib is recommended and the patient should be monitored closely. Once transaminases have returned to baseline values, treatment with Nintedanib may be resumed at the full dose (150 mg twice daily) or reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose. If any liver test elevations are associated with clinical signs or symptoms of liver injury, e.g. jaundice, treatment with Nintedanib should be permanently discontinued. Alternative causes of the liver enzyme elevations should be investigated.

Patients with low body weight (<65 kg), Asian and female patients have a higher risk of elevations of liver enzymes. Nintedanib exposure increased linearly with patient age, which may also result in a higher risk of developing liver enzyme elevations. Close monitoring is recommended in patients with these risk factors.

Renal Function: Cases of renal impairment/failure, in some cases with fatal outcome, have been reported with Nintedanib use. Patients should be monitored during Nintedanib therapy, with particular attention to those patients exhibiting risk factors for renal impairment/failure. In case of renal impairment/failure, therapy adjustment should be considered.

Haemorrhage: Vascular endothelial growth factor receptor (VEGFR) inhibition might be associated with an increased risk of bleeding. In the INPULSIS trials with Nintedanib, the frequency of patients who experienced bleeding AEs was slightly higher in the Nintedanib arm (10.3%) than in the placebo arm (7.8%). Non-serious epistaxis was the most frequent bleeding event. Serious bleeding events occurred with low and similar frequencies in the 2 treatment groups (placebo: 1.4%; Nintedanib: 1.3%). Patients at known risk for bleeding including patients with inherited predisposition to bleeding or patients receiving a full dose of anti-coagulative treatment were not included in the INPULSIS studies. Non-serious and serious bleeding events, some of which were fatal, have been reported in the post-marketing period (including patients with or without anticoagulant therapy or other drugs that could cause bleeding). Therefore, these patients should only be treated with Nintedanib if the anticipated benefit outweighs the potential risk. Post-marketing bleeding events include but are not limited to gastrointestinal, respiratory and central nervous organ systems, with the most frequent being gastrointestinal.

Arterial thromboembolic events: Patients with a recent history of myocardial infarction or stroke were excluded from the INPULSIS trials. Arterial thromboembolic events were infrequently reported: in 0.7% of patients in the placebo and 2.5% in the Nintedanib treated group. While adverse events reflecting ischemic heart disease were balanced between the Nintedanib and placebo groups, a higher percentage of patients experienced myocardial infarctions in the Nintedanib group (1.6%) compared to the placebo group (0.5%). Caution should be used when treating patients at higher cardiovascular risk including known coronary artery disease. Treatment interruption should be considered in patients who develop signs or symptoms of acute myocardial ischemia.

Venous thromboembolism: In the INPULSIS trials no increased risk of venous thromboembolism was observed in Nintedanib treated patients. Due to the mechanism of action of Nintedanib patients might have an increased risk of thromboembolic events.

Gastrointestinal perforations: In the INPULSIS trials, the frequency of patients with perforation was very low in both treatment groups: 0% placebo, 0.3% Nintedanib (involving two patients). Due to the mechanism of action of Nintedanib patients might have an increased risk of gastrointestinal perforation. Cases of gastrointestinal perforations, some of which were fatal, have been reported in the post-marketing period. Particular caution should be exercised when treating patients with previous abdominal surgery, previous history of peptic ulceration, diverticular disease or receiving concomitant corticosteroids or NSAIDs. Nintedanib should only be initiated at least 4 weeks after abdominal surgery. Therapy with Nintedanib should be permanently discontinued in patients who develop gastrointestinal perforation.

Hypertension: Administration of Nintedanib may increase blood pressure. Systemic blood pressure should be measured periodically and as clinically indicated.

Wound healing complication: No increased frequency of impaired wound healing was observed in the INPULSIS trials. Based on the mechanism of action Nintedanib may impair wound healing. No dedicated studies investigating the effect of Nintedanib on wound healing were performed. Treatment with Nintedanib should therefore only be initiated or – in case of perioperative interruption – resumed based on clinical judgement of adequate wound healing.

Co-administration with Pirfenidone: In a dedicated pharmacokinetic study, concomitant treatment of Nintedanib with Pirfenidone was investigated in patients with IPF. Based on these results, there is no evidence of a relevant pharmacokinetic drug-drug interaction between Nintedanib and Pirfenidone when administered in combination. In view of the limited number of patients, this study detected only the most frequent adverse events and showed an increase in gastrointestinal adverse events and a trend toward increased hepatic adverse events. Given the similarity in safety profiles for both medicinal products, additive adverse events, including gastrointestinal and hepatic adverse events, may be expected. The benefit-risk balance of concomitant treatment with Pirfenidone has not been established.

Effect on QT interval: No evidence of QT prolongation was observed for Nintedanib in the clinical trial programme. As some other tyrosine kinase inhibitors are known to exert an effect on QT, caution should be exercised when administered Nintedanib in patients who may develop QTc prolongation.

Allergic reaction: Dietary soya products are known to cause allergic reactions including severe anaphylaxis in persons with soya allergy. Patients with known allergy to peanut protein carry an enhanced risk for severe reactions to soya preparations.

InteractionsView

P-glycoprotein (P-gp): Nintedanib is a substrate of P-gp. Co-administration with the potent P-gp inhibitor ketoconazole increased exposure to Nintedanib 1.61-fold based on AUC and 1.83-fold based on Cmax in a dedicated drug-drug interaction study. In a drug-drug interaction study with the potent P-gp inducer rifampicin, exposure to Nintedanib decreased to 50.3% based on AUC and to 60.3% based on Cmax upon co-administration with rifampicin compared to administration of Nintedanib alone. If co-administered with Nintedanib, potent P-gp inhibitors (e.g. ketoconazole, erythromycin or cyclosporine) may increase exposure to Nintedanib. In such cases, patients should be monitored closely for tolerability of Nintedanib. Management of side effects may require interruption, dose reduction, or discontinuation of therapy with Nintedanib. Potent P-gp inducers (e.g. rifampicin, carbamazepine, phenytoin, and St. John’s Wort) may decrease exposure to Nintedanib. Selection of an alternate concomitant medicinal product with no or minimal P-gp induction potential should be considered.

Cytochrome (CYP)-enzymes: Only a minor extent of the biotransformation of Nintedanib consisted of CYP pathways. Nintedanib and its metabolites, the free acid moiety BIBF 1202 and its glucuronide BIBF 1202 glucuronide, did not inhibit or induce CYP enzymes in preclinical studies. The likelihood of drug-drug interactions with Nintedanib based on CYP metabolism is therefore considered to be low.

Co-administration with other medicinal products: The potential for interactions of Nintedanib with hormonal contraceptives was not explored.

Pregnancy & lactationView

Women of childbearing potential/Contraception: Nintedanib may cause foetalharm in humans. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Nintedanib. They should be advised to use adequate contraception during and at least 3 months after the last dose of Nintedanib. Since the effect of Nintedanib on the metabolism and efficacy of hormonal contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy.

Pregnancy: There is no information on the use of Nintedanib in pregnant women, but pre-clinical studies in animals have shown reproductive toxicity of this active substance. As Nintedanib may cause foetal harm also in humans, it must not be used during pregnancy. Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy with Nintedanib. If the patient becomes pregnant while receiving Nintedanib, she should be apprised of the potential hazard to the foetus. Termination of the treatment with Nintedanib should be considered.

Lactation: There is no information on the excretion of Nintedanib and its metabolites in human milk. Pre-clinical studies showed that small amounts of Nintedanib and its metabolites (≤ 0.5% of the administered dose) were secreted into milk of lactating rats. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with Nintedanib.

Fertility: Based on preclinical investigations there is no evidence for impairment of male fertility. From subchronic and chronic toxicity studies, there is no evidence that female fertility in rats is impaired at a systemic exposure level comparable with that at the maximum recommended human dose (MRHD) of 150 mg twice daily.

Pediatric usageView

Elderly patients (≥65 years): No overall differences in safety and efficacy were observed for elderly patients. No a-priori dose adjustment is required on the basis of a patient’s age. Patients ≥75 years may be more likely to require dose reduction to manage adverse effects.

Renal impairment: Less than 1% of a single dose of Nintedanib is excreted via the kidney. Adjustment of the starting dose in patients with mild to moderate renal impairment is not required. The safety, efficacy, and pharmacokinetics of Nintedanib have not been studied in patients with severe renal impairment (<30 ml/min creatinine clearance).

Hepatic impairment: Nintedanib is predominantly eliminated via biliary/faecal excretion (> 90%). Exposure increased in patients with hepatic impairment (Child Pugh A, Child Pugh B). In patients with mild hepatic impairment (Child Pugh A), the recommended dose of Nintedanib is 100 mg twice daily approximately 12 hours apart. In patients with mild hepatic impairment (Child Pugh A), treatment interruption or discontinuation for management of adverse reactions should be considered. The safety and efficacy of Nintedanib have not been investigated in patients with hepatic impairment classified as Child Pugh B and C. Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Nintedanib is not recommended.

Paediatric population: The safety and efficacy of Nintedanib in children aged 0-18 years have not been established. No data are available.

StorageView

Store in a cool and dry place, protected from light. Do not store above 25°C.

Ficef

Cefadroxil Monohydrate

Powder for Suspension 125 mg/5 ml Allopathic First generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

It is indicated for the treatment of upper respiratory tract infections (pharyngitis and tonsillitis) caused by Streptococcus pyogenes (group-A beta-hemolytic Streptococci) and Streptococcus pneumoniae; urinary tract infections caused by E. coli, Proteus mirabilis, and Klebsiella species and skin & soft tissue infections caused by Staphylococci (including penicillinase producing bacteria) and Streptococci.

Therapeutic classView

First generation Cephalosporins

PharmacologyView

Cefadroxil inhibits bacterial cell wall synthesis by binding to 1 or more of the penicillin-binding proteins (PBPs) which in turn inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis and arresting cell wall assembly resulting in bacterial cell death.

DosageView

Adult:

Pharyngitis and Tonsillitis: 1 g per day in one or two divided doses.
Urinary Tract Infections: 1 or 2 g per day in one or two divided doses.
Skin and Skin Structure Infections: 1 g per day in one or two divided doses.

Children: 30 mg/kg daily in divided doses every 12 hours.

It may be taken with meals or on empty stomach. Administration with food may be helpful in diminishing potential gastrointestinal complaints.

Side effectsView

Generally Cefadroxil is well tolerated. However, the most commonly reported side effects are gastrointestinal disturbances and hypersensitivity phenomena.

ContraindicationsView

Cefadroxil is contraindicated in patients with a history of hypersensitivity to Cefadroxil or any of the ingredients of it.

PrecautionsView

Use of this antibiotic may cause pseudomembranous colitis; so caution should be taken during diagnosis in patients who develop diarrhea in association with Cefadroxil therapy.

InteractionsView

There is no significant drug interaction with other drugs.

Pregnancy & lactationView

US FDA pregnancy category of Cefadroxil is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefadroxil have been shown to be excreted in human milk. So, caution should be exercised when Cefadroxil is administered during lactation.

StorageView

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

Ficef

Cefadroxil Monohydrate

Capsule 500 mg Allopathic First generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

It is indicated for the treatment of upper respiratory tract infections (pharyngitis and tonsillitis) caused by Streptococcus pyogenes (group-A beta-hemolytic Streptococci) and Streptococcus pneumoniae; urinary tract infections caused by E. coli, Proteus mirabilis, and Klebsiella species and skin & soft tissue infections caused by Staphylococci (including penicillinase producing bacteria) and Streptococci.

Therapeutic classView

First generation Cephalosporins

PharmacologyView

Cefadroxil inhibits bacterial cell wall synthesis by binding to 1 or more of the penicillin-binding proteins (PBPs) which in turn inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis and arresting cell wall assembly resulting in bacterial cell death.

DosageView

Adult:

Pharyngitis and Tonsillitis: 1 g per day in one or two divided doses.
Urinary Tract Infections: 1 or 2 g per day in one or two divided doses.
Skin and Skin Structure Infections: 1 g per day in one or two divided doses.

Children: 30 mg/kg daily in divided doses every 12 hours.

It may be taken with meals or on empty stomach. Administration with food may be helpful in diminishing potential gastrointestinal complaints.

Side effectsView

Generally Cefadroxil is well tolerated. However, the most commonly reported side effects are gastrointestinal disturbances and hypersensitivity phenomena.

ContraindicationsView

Cefadroxil is contraindicated in patients with a history of hypersensitivity to Cefadroxil or any of the ingredients of it.

PrecautionsView

Use of this antibiotic may cause pseudomembranous colitis; so caution should be taken during diagnosis in patients who develop diarrhea in association with Cefadroxil therapy.

InteractionsView

There is no significant drug interaction with other drugs.

Pregnancy & lactationView

US FDA pregnancy category of Cefadroxil is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefadroxil have been shown to be excreted in human milk. So, caution should be exercised when Cefadroxil is administered during lactation.

StorageView

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

Ficlox

Cloxacillin Sodium

Injection 500 mg/vial Allopathic Penicillinase-resistant penicillins

Indications

UTI caused by Staphylococcus Aureus

Indication detailsView

গ্রাম-পজিটিভ জীবাণু দ্বারা সৃষ্ট সংক্রমণের চিকিৎসায় ক্লক্সাসিলিন নির্দেশিত। পেনিসিলিনেজ উৎপাদনক্ষম স্টেফাইলোকক্কাই জনিত সংক্রমণের চিকিৎসায়ও এটি নির্দেশিত। এ জাতীয় সংক্রমণের মধ্যে রয়েছেঃ

স্কিন ও সফ্‌ট টিস্যু সংক্রমণ: ফোঁড়া (boils), পূজাশয় (abscess), কার্বাংকল, ফারানকুলোসিস, সেলুলাইটিস, সংক্রমিত ক্ষত (infected wounds), সংক্রমিত পোড়া (infected burns), ত্বক প্রতিস্থাপন প্রতিরক্ষা (protection for skin grafts), ত্বকের বিভিন্ন সংক্রমণ যেমন আলসার, একজিমা ও একনি।

রেসপিরেটরী ট্র্যাক্ট, নাক, কান ও গলার সংক্রমণ: নিউমোনিয়া, ফুসফুসের পূজাশয় (lung abscess), এমপায়েমা, সাইনোসাইটিস, ফ্যারিনজাইটিস, টনসিলাইটিস, কুইনসি, অটাইটিস মিডিয়া ও এক্সটারণা।

ক্লক্সাসিলিন-সংবেদনশীল (sensitive), জীবাণু জনিত অন্যান্য সংক্রমণ: অসটিওমায়েলাইটিস, এনটেরাইটিস, এনডোকারডাইটিস, ইউরিনারী ট্র্যাক্ট সংক্রমণ ও সেপটিসেমিয়া।

Therapeutic classView

Penicillinase-resistant penicillins

DosageView

প্রাপ্তবয়স্কদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ৫০০ মিগ্রা দিনে চার বার আহারের আধা থেকে এক ঘন্টা আগে।
ইনজেকশন হিসেবে:

মাংসপেশীতে ইনজেকশন হিসেবে: ২৫০ মিগ্রা চার থেকে ছয় ঘন্টা পর পর।
শিরাপথে ইনজেকশন হিসেবে: ৫০০ মিগ্রা চার থেকে ছয় ঘন্টা পর পর। প্রয়োজনবোধে উপরোল্লিখিত মাত্রাকে দ্বিগুণ করা যেতে পারে।
প্লুরাল কেভিটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা দিনে এক বার।
জয়েন্ট কেভিটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা দিনে এক বার।

শিশুদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ২ থেকে ১০ বৎসর পর্যন্ত- প্রাপ্তবয়স্ক মাত্রার অর্ধেক। ২ বৎসরের নীচে- প্রাপ্তবয়স্ক মাত্রার এক-চতুর্থাংশ।
ইনজেকশন হিসেবে:

মাংসপেশীতে ইনজেকশন হিসেবে: ২৫০ মিগ্রা এর সাথে ১.৫ মিলি কিংবা ৫০০ মিগ্রা এর সাথে ২ মিলি ওয়াটার ফর ইনজেকশন বিপি মিশিয়ে দ্রবীভূত করতে হবে।
শিরাপথে ইনজকেশন হিসাবে: ৫০০ মিগ্রা এর সাথে ৫-১০ মিলি ওয়াটার ফর ইনজকেশন বিপি মিশিয়ে দ্রবীভূত করতে হবে। এরপর এই দ্রবণকে তিন থেকে চার মিনিট ধরে ধীরে ধীরে শরীরে প্রয়োগ করতে হবে। ক্লক্সাসিলিন ইনজকেশনকে ইনফিউশন উপযোগী যে কোন তরলে মিশিয়ে দেয়া যায় অথবা যথাযথ ভাবে হালকা করে ড্রপি টউিবে তিন থেকে চার মিনিট ধরে ধীরে ধীরে প্রয়োগ করা যায়।
প্লুরাল কেভেটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা এর সাথে ৫ থেকে ১০ মিলি ওয়াটার ফর ইনজকেশন বিপি মিশিয়ে দ্রবীভূত করে প্রয়োগ করতে হবে।
জয়েন্টে কেভেটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা এর সাথে অনধকি ৫ মিলি ওয়াটার ফর ইনজকেশন বিপি অথবা ০.৫% লিগনোকেইন হাইড্রোক্লোরাইড দ্রবণ মিশিয়ে দ্রবীভূত করে প্রয়োগ করতে হবে।

Side effectsView

ক্লক্সাসিলিন এর পার্শ্ব-প্রতিক্রিয়া অন্যান্য পেনিসিলিনের মতই। এগুলো সাধারণতঃ মৃদু ও ক্ষণস্থায়ী হয়ে থাকে। এই সমস্ত পার্শ্ব-প্রতিক্রিয়ার মধ্যে রয়েছে জ্বর, ডায়রিয়া, অজীর্ণ (indigestion), র‍্যাশ-আরটিকারিয়েল অথবা ইরিথিমেটাস জাতীয়। যে কোন ধরণের র‍্যাশে রোগীকে এ ওষুধ দেয়া বন্ধ করতে হবে।

ContraindicationsView

পেনিসিলিনে অতি-সংবেদনশীল (hypersensitive) রোগীদের ক্ষেত্রে ক্লক্সাসিলিন প্রয়োগ নিষিদ্ধ।

PrecautionsView

যে সব রোগীর এলার্জির পূর্ব ইতিহাস আছে তাদের বেলায় ক্লক্সাসিলিন সতর্কতার সাথে ব্যবহার করতে হবে। ক্লক্সাসিলিন সাব-কনজাংটিভাল ইনজেকশন হিসেবে অথবা চোখের ড্রপস হিসেবে দেয়া যাবে না।

ক্লক্সাসিলিন সিরাপ ও ড্রপস ব্যবহরের আগে তাৎক্ষনিকভাবে তৈরী করে ঠাণ্ডা স্থানে (সম্ভব হলে রেফ্রিজারেটরে) রাখতে হবে। সংমিশ্রিত সিরাপ ও ড্রপস সাধারণ তাপমাত্রায় রাখলে পাঁচ দিনের মধ্যে অথবা রেফ্রিজারেটরে রাখলে সাত দিনের মধ্যে ব্যবহার করতে হবে। মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য প্রস্তুতকৃত ক্লক্সাসিলিন দ্রবণ তৈরীর ৩০ মিনিটের মধ্যে ব্যবহার করতে হবে। অবশ্য ক্লক্সাসিলিন এর জলীয় দ্রবণ স্বাভাবিক তাপমাত্রায় (২৫° সেঃ) অনধিক ২৪ ঘন্টা পর্যন্ত কার্যকর থাকে।

শিরাপথের প্রয়োগোপযোগী অধিকাংশ তরলের সাথেই ক্লক্সাসিলিন মেশানো যায়। তবে কখনোই আমিষ জাতীয় তরল (যেমন প্রোটিন হাইড্রোলাইসেটস) এর সাথে মেশানো যাবে না।

StorageView

ক্লক্সাসিলিন এর সকল ডোসেজ ফরমকে ঠান্ডা ও শুকনো স্থানে রাখতে হবে। ক্লক্সাসিলিন ইনজেকশন ভায়ালকে অনধিক ২৫° সেঃ তাপমাত্রায় সংরক্ষণ করুন।

Ficlox

Cloxacillin Sodium

Powder for Suspension 125 mg/5 ml Allopathic Penicillinase-resistant penicillins

Indications

UTI caused by Staphylococcus Aureus

Indication detailsView

গ্রাম-পজিটিভ জীবাণু দ্বারা সৃষ্ট সংক্রমণের চিকিৎসায় ক্লক্সাসিলিন নির্দেশিত। পেনিসিলিনেজ উৎপাদনক্ষম স্টেফাইলোকক্কাই জনিত সংক্রমণের চিকিৎসায়ও এটি নির্দেশিত। এ জাতীয় সংক্রমণের মধ্যে রয়েছেঃ

স্কিন ও সফ্‌ট টিস্যু সংক্রমণ: ফোঁড়া (boils), পূজাশয় (abscess), কার্বাংকল, ফারানকুলোসিস, সেলুলাইটিস, সংক্রমিত ক্ষত (infected wounds), সংক্রমিত পোড়া (infected burns), ত্বক প্রতিস্থাপন প্রতিরক্ষা (protection for skin grafts), ত্বকের বিভিন্ন সংক্রমণ যেমন আলসার, একজিমা ও একনি।

রেসপিরেটরী ট্র্যাক্ট, নাক, কান ও গলার সংক্রমণ: নিউমোনিয়া, ফুসফুসের পূজাশয় (lung abscess), এমপায়েমা, সাইনোসাইটিস, ফ্যারিনজাইটিস, টনসিলাইটিস, কুইনসি, অটাইটিস মিডিয়া ও এক্সটারণা।

ক্লক্সাসিলিন-সংবেদনশীল (sensitive), জীবাণু জনিত অন্যান্য সংক্রমণ: অসটিওমায়েলাইটিস, এনটেরাইটিস, এনডোকারডাইটিস, ইউরিনারী ট্র্যাক্ট সংক্রমণ ও সেপটিসেমিয়া।

Therapeutic classView

Penicillinase-resistant penicillins

DosageView

প্রাপ্তবয়স্কদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ৫০০ মিগ্রা দিনে চার বার আহারের আধা থেকে এক ঘন্টা আগে।
ইনজেকশন হিসেবে:

মাংসপেশীতে ইনজেকশন হিসেবে: ২৫০ মিগ্রা চার থেকে ছয় ঘন্টা পর পর।
শিরাপথে ইনজেকশন হিসেবে: ৫০০ মিগ্রা চার থেকে ছয় ঘন্টা পর পর। প্রয়োজনবোধে উপরোল্লিখিত মাত্রাকে দ্বিগুণ করা যেতে পারে।
প্লুরাল কেভিটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা দিনে এক বার।
জয়েন্ট কেভিটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা দিনে এক বার।

শিশুদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ২ থেকে ১০ বৎসর পর্যন্ত- প্রাপ্তবয়স্ক মাত্রার অর্ধেক। ২ বৎসরের নীচে- প্রাপ্তবয়স্ক মাত্রার এক-চতুর্থাংশ।
ইনজেকশন হিসেবে:

মাংসপেশীতে ইনজেকশন হিসেবে: ২৫০ মিগ্রা এর সাথে ১.৫ মিলি কিংবা ৫০০ মিগ্রা এর সাথে ২ মিলি ওয়াটার ফর ইনজেকশন বিপি মিশিয়ে দ্রবীভূত করতে হবে।
শিরাপথে ইনজকেশন হিসাবে: ৫০০ মিগ্রা এর সাথে ৫-১০ মিলি ওয়াটার ফর ইনজকেশন বিপি মিশিয়ে দ্রবীভূত করতে হবে। এরপর এই দ্রবণকে তিন থেকে চার মিনিট ধরে ধীরে ধীরে শরীরে প্রয়োগ করতে হবে। ক্লক্সাসিলিন ইনজকেশনকে ইনফিউশন উপযোগী যে কোন তরলে মিশিয়ে দেয়া যায় অথবা যথাযথ ভাবে হালকা করে ড্রপি টউিবে তিন থেকে চার মিনিট ধরে ধীরে ধীরে প্রয়োগ করা যায়।
প্লুরাল কেভেটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা এর সাথে ৫ থেকে ১০ মিলি ওয়াটার ফর ইনজকেশন বিপি মিশিয়ে দ্রবীভূত করে প্রয়োগ করতে হবে।
জয়েন্টে কেভেটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা এর সাথে অনধকি ৫ মিলি ওয়াটার ফর ইনজকেশন বিপি অথবা ০.৫% লিগনোকেইন হাইড্রোক্লোরাইড দ্রবণ মিশিয়ে দ্রবীভূত করে প্রয়োগ করতে হবে।

Side effectsView

ক্লক্সাসিলিন এর পার্শ্ব-প্রতিক্রিয়া অন্যান্য পেনিসিলিনের মতই। এগুলো সাধারণতঃ মৃদু ও ক্ষণস্থায়ী হয়ে থাকে। এই সমস্ত পার্শ্ব-প্রতিক্রিয়ার মধ্যে রয়েছে জ্বর, ডায়রিয়া, অজীর্ণ (indigestion), র‍্যাশ-আরটিকারিয়েল অথবা ইরিথিমেটাস জাতীয়। যে কোন ধরণের র‍্যাশে রোগীকে এ ওষুধ দেয়া বন্ধ করতে হবে।

ContraindicationsView

পেনিসিলিনে অতি-সংবেদনশীল (hypersensitive) রোগীদের ক্ষেত্রে ক্লক্সাসিলিন প্রয়োগ নিষিদ্ধ।

PrecautionsView

যে সব রোগীর এলার্জির পূর্ব ইতিহাস আছে তাদের বেলায় ক্লক্সাসিলিন সতর্কতার সাথে ব্যবহার করতে হবে। ক্লক্সাসিলিন সাব-কনজাংটিভাল ইনজেকশন হিসেবে অথবা চোখের ড্রপস হিসেবে দেয়া যাবে না।

ক্লক্সাসিলিন সিরাপ ও ড্রপস ব্যবহরের আগে তাৎক্ষনিকভাবে তৈরী করে ঠাণ্ডা স্থানে (সম্ভব হলে রেফ্রিজারেটরে) রাখতে হবে। সংমিশ্রিত সিরাপ ও ড্রপস সাধারণ তাপমাত্রায় রাখলে পাঁচ দিনের মধ্যে অথবা রেফ্রিজারেটরে রাখলে সাত দিনের মধ্যে ব্যবহার করতে হবে। মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য প্রস্তুতকৃত ক্লক্সাসিলিন দ্রবণ তৈরীর ৩০ মিনিটের মধ্যে ব্যবহার করতে হবে। অবশ্য ক্লক্সাসিলিন এর জলীয় দ্রবণ স্বাভাবিক তাপমাত্রায় (২৫° সেঃ) অনধিক ২৪ ঘন্টা পর্যন্ত কার্যকর থাকে।

শিরাপথের প্রয়োগোপযোগী অধিকাংশ তরলের সাথেই ক্লক্সাসিলিন মেশানো যায়। তবে কখনোই আমিষ জাতীয় তরল (যেমন প্রোটিন হাইড্রোলাইসেটস) এর সাথে মেশানো যাবে না।

StorageView

ক্লক্সাসিলিন এর সকল ডোসেজ ফরমকে ঠান্ডা ও শুকনো স্থানে রাখতে হবে। ক্লক্সাসিলিন ইনজেকশন ভায়ালকে অনধিক ২৫° সেঃ তাপমাত্রায় সংরক্ষণ করুন।

Ficlox

Cloxacillin Sodium

Capsule 500 mg Allopathic Penicillinase-resistant penicillins

Indications

UTI caused by Staphylococcus Aureus

Indication detailsView

গ্রাম-পজিটিভ জীবাণু দ্বারা সৃষ্ট সংক্রমণের চিকিৎসায় ক্লক্সাসিলিন নির্দেশিত। পেনিসিলিনেজ উৎপাদনক্ষম স্টেফাইলোকক্কাই জনিত সংক্রমণের চিকিৎসায়ও এটি নির্দেশিত। এ জাতীয় সংক্রমণের মধ্যে রয়েছেঃ

স্কিন ও সফ্‌ট টিস্যু সংক্রমণ: ফোঁড়া (boils), পূজাশয় (abscess), কার্বাংকল, ফারানকুলোসিস, সেলুলাইটিস, সংক্রমিত ক্ষত (infected wounds), সংক্রমিত পোড়া (infected burns), ত্বক প্রতিস্থাপন প্রতিরক্ষা (protection for skin grafts), ত্বকের বিভিন্ন সংক্রমণ যেমন আলসার, একজিমা ও একনি।

রেসপিরেটরী ট্র্যাক্ট, নাক, কান ও গলার সংক্রমণ: নিউমোনিয়া, ফুসফুসের পূজাশয় (lung abscess), এমপায়েমা, সাইনোসাইটিস, ফ্যারিনজাইটিস, টনসিলাইটিস, কুইনসি, অটাইটিস মিডিয়া ও এক্সটারণা।

ক্লক্সাসিলিন-সংবেদনশীল (sensitive), জীবাণু জনিত অন্যান্য সংক্রমণ: অসটিওমায়েলাইটিস, এনটেরাইটিস, এনডোকারডাইটিস, ইউরিনারী ট্র্যাক্ট সংক্রমণ ও সেপটিসেমিয়া।

Therapeutic classView

Penicillinase-resistant penicillins

DosageView

প্রাপ্তবয়স্কদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ৫০০ মিগ্রা দিনে চার বার আহারের আধা থেকে এক ঘন্টা আগে।
ইনজেকশন হিসেবে:

মাংসপেশীতে ইনজেকশন হিসেবে: ২৫০ মিগ্রা চার থেকে ছয় ঘন্টা পর পর।
শিরাপথে ইনজেকশন হিসেবে: ৫০০ মিগ্রা চার থেকে ছয় ঘন্টা পর পর। প্রয়োজনবোধে উপরোল্লিখিত মাত্রাকে দ্বিগুণ করা যেতে পারে।
প্লুরাল কেভিটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা দিনে এক বার।
জয়েন্ট কেভিটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা দিনে এক বার।

শিশুদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ২ থেকে ১০ বৎসর পর্যন্ত- প্রাপ্তবয়স্ক মাত্রার অর্ধেক। ২ বৎসরের নীচে- প্রাপ্তবয়স্ক মাত্রার এক-চতুর্থাংশ।
ইনজেকশন হিসেবে:

মাংসপেশীতে ইনজেকশন হিসেবে: ২৫০ মিগ্রা এর সাথে ১.৫ মিলি কিংবা ৫০০ মিগ্রা এর সাথে ২ মিলি ওয়াটার ফর ইনজেকশন বিপি মিশিয়ে দ্রবীভূত করতে হবে।
শিরাপথে ইনজকেশন হিসাবে: ৫০০ মিগ্রা এর সাথে ৫-১০ মিলি ওয়াটার ফর ইনজকেশন বিপি মিশিয়ে দ্রবীভূত করতে হবে। এরপর এই দ্রবণকে তিন থেকে চার মিনিট ধরে ধীরে ধীরে শরীরে প্রয়োগ করতে হবে। ক্লক্সাসিলিন ইনজকেশনকে ইনফিউশন উপযোগী যে কোন তরলে মিশিয়ে দেয়া যায় অথবা যথাযথ ভাবে হালকা করে ড্রপি টউিবে তিন থেকে চার মিনিট ধরে ধীরে ধীরে প্রয়োগ করা যায়।
প্লুরাল কেভেটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা এর সাথে ৫ থেকে ১০ মিলি ওয়াটার ফর ইনজকেশন বিপি মিশিয়ে দ্রবীভূত করে প্রয়োগ করতে হবে।
জয়েন্টে কেভেটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা এর সাথে অনধকি ৫ মিলি ওয়াটার ফর ইনজকেশন বিপি অথবা ০.৫% লিগনোকেইন হাইড্রোক্লোরাইড দ্রবণ মিশিয়ে দ্রবীভূত করে প্রয়োগ করতে হবে।

Side effectsView

ক্লক্সাসিলিন এর পার্শ্ব-প্রতিক্রিয়া অন্যান্য পেনিসিলিনের মতই। এগুলো সাধারণতঃ মৃদু ও ক্ষণস্থায়ী হয়ে থাকে। এই সমস্ত পার্শ্ব-প্রতিক্রিয়ার মধ্যে রয়েছে জ্বর, ডায়রিয়া, অজীর্ণ (indigestion), র‍্যাশ-আরটিকারিয়েল অথবা ইরিথিমেটাস জাতীয়। যে কোন ধরণের র‍্যাশে রোগীকে এ ওষুধ দেয়া বন্ধ করতে হবে।

ContraindicationsView

পেনিসিলিনে অতি-সংবেদনশীল (hypersensitive) রোগীদের ক্ষেত্রে ক্লক্সাসিলিন প্রয়োগ নিষিদ্ধ।

PrecautionsView

যে সব রোগীর এলার্জির পূর্ব ইতিহাস আছে তাদের বেলায় ক্লক্সাসিলিন সতর্কতার সাথে ব্যবহার করতে হবে। ক্লক্সাসিলিন সাব-কনজাংটিভাল ইনজেকশন হিসেবে অথবা চোখের ড্রপস হিসেবে দেয়া যাবে না।

ক্লক্সাসিলিন সিরাপ ও ড্রপস ব্যবহরের আগে তাৎক্ষনিকভাবে তৈরী করে ঠাণ্ডা স্থানে (সম্ভব হলে রেফ্রিজারেটরে) রাখতে হবে। সংমিশ্রিত সিরাপ ও ড্রপস সাধারণ তাপমাত্রায় রাখলে পাঁচ দিনের মধ্যে অথবা রেফ্রিজারেটরে রাখলে সাত দিনের মধ্যে ব্যবহার করতে হবে। মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য প্রস্তুতকৃত ক্লক্সাসিলিন দ্রবণ তৈরীর ৩০ মিনিটের মধ্যে ব্যবহার করতে হবে। অবশ্য ক্লক্সাসিলিন এর জলীয় দ্রবণ স্বাভাবিক তাপমাত্রায় (২৫° সেঃ) অনধিক ২৪ ঘন্টা পর্যন্ত কার্যকর থাকে।

শিরাপথের প্রয়োগোপযোগী অধিকাংশ তরলের সাথেই ক্লক্সাসিলিন মেশানো যায়। তবে কখনোই আমিষ জাতীয় তরল (যেমন প্রোটিন হাইড্রোলাইসেটস) এর সাথে মেশানো যাবে না।

StorageView

ক্লক্সাসিলিন এর সকল ডোসেজ ফরমকে ঠান্ডা ও শুকনো স্থানে রাখতে হবে। ক্লক্সাসিলিন ইনজেকশন ভায়ালকে অনধিক ২৫° সেঃ তাপমাত্রায় সংরক্ষণ করুন।

Fightex

Cefuroxime Axetil

Tablet 500 mg Allopathic Second generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

It is indicated for the treatment of infections caused by sensitive bacteria.

Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli
Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.

Therapeutic classView

Second generation Cephalosporins

PharmacologyView

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

DosageView

Tablet or Suspension-

Adolescents and adults (13 years and older)-

Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
Uncomplicated Gonorrhoea: 1000 mg Single dose
Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
Acute otitis media: 30 mg/kg/day b.i.d for 10 days
Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

Adult: 3 gm IV injection three times daily.
Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

Adult: 1.5 gm IV injection four times daily.
Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

AdministrationView

The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

Side effectsView

Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

ContraindicationsView

Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.

PrecautionsView

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

InteractionsView

No potentially hazardous interactions have been reported.

Pregnancy & lactationView

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

ReconstitutionView

For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

StorageView

Store in a cool, dry place (below 30^o C), away from light & moisture. Keep out of the reach of children.

Fightex

Cefuroxime Axetil

Tablet 250 mg Allopathic Second generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

It is indicated for the treatment of infections caused by sensitive bacteria.

Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli
Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.

Therapeutic classView

Second generation Cephalosporins

PharmacologyView

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

DosageView

Tablet or Suspension-

Adolescents and adults (13 years and older)-

Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
Uncomplicated Gonorrhoea: 1000 mg Single dose
Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
Acute otitis media: 30 mg/kg/day b.i.d for 10 days
Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

Adult: 3 gm IV injection three times daily.
Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

Adult: 1.5 gm IV injection four times daily.
Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

AdministrationView

The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5^o C

Side effectsView

Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

ContraindicationsView

Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.

PrecautionsView

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.

InteractionsView

No potentially hazardous interactions have been reported.

Pregnancy & lactationView

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

ReconstitutionView

For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

StorageView

Store in a cool, dry place (below 30^o C), away from light & moisture. Keep out of the reach of children.

Filastin

Filgrastim

IV/SC Injection 300 mcg/0.5 ml Allopathic Haematopoietic Agents

Indications

Peripheral blood progenitor cell collection and therapy

Indication detailsView

Filgrastim is indicated to those:

Cancer patients receiving myelosuppressive chemotherapy
Patients with Acute Myeloid Leukemia receiving induction or consolidation chemotherapy
Cancer patients receiving bone marrow transplant
Patients with severe neutropenia
Peripheral blood progenitor cell collection and therapy

Therapeutic classView

Haematopoietic Agents

PharmacologyView

Filgrastim is a granulocyte-colony stimulating factor which binds to cell surface receptors on haemetopoietic cells thus stimulating the development of granulocytes to increase their migration and cytotoxicity.

Filgrastim is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow. Filgrastim causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes. Elevations of neutrophil counts are dose-dependent at recommended doses. Following termination of Filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 to 2 days, and to normal levels within 1 to 7 days.

DosageView

Parenteral-

Chemotherapy-induced neutropenia: 5 mcg/kg daily as a single daily SC inj, as a continuous IV or SC infusion, or as a daily IV infusion over 15-30 minutes, starting not

Bone marrow transplantation: 10 mcg/kg daily by IV infusion over 30 min or 4 hr or continuous IV or SC infusion over 24 hr. Adjust according to response.

Subcutaneous-

Mobilisation of peripheral blood progenitor cells for autologous peripheral blood stem cell transplantation: 10 mcg/kg daily, as a single inj or by continuous infusion, for 4-7 days until the last leucapheresis procedure. If it is given after myelosuppressive chemotherapy: 5 mcg/kg daily by inj; given from the 1st day after chemotherapy completion until expected neutrophil nadir is passed and neutrophil count has returned to normal range, so that leucapheresis can be performed.

Congenital neutropenia: 12 mcg/kg daily in single or divided doses. Adjust according to response. In patients with cyclic or idiopathic neutropenia: 5 mcg/kg daily in single or divided doses. Adjust according to response.

HIV infection and persistent neutropenia: Initially, 1 mcg/kg daily. Dose may be increased to 4 mcg/kg daily until normal neutrophil count is achieved. Maintenance: 300 mcg daily. Max: 4 mcg/kg daily.

Side effectsView

Musculoskeletal pain, bone pain, hypersensitivity reactions, splenic enlargement, hepatomegaly, thrombocytopaenia, anaemia, epistaxis, headache, nausea, vomiting, diarrhoea, urinary abnormalities (dysuria, proteinuria, haematuria), osteoporosis, exacerbation of rheumatoid arthritis, transient decrease in blood glucose, raised uric acid, cutaneous vasculitis, transient hypotension.

ContraindicationsView

Filgrastim is contraindicated in patients hypersensitive to the drug, any ingredient in the formulation, or proteins derived from Escherichia coli.

PrecautionsView

Filgrastim should not be administered within 24 hours before and after chemotherapy The possibility of Filgrastim acting as a growth factor for any tumor type cannot be excluded. To avoid adverse effects of excessive neutrophils complete blood count is recommended twice per week during treatment. Filgrastim is given by subcutaneous or intravenous infusion as required

InteractionsView

Drug interactions between Filgrastim and other drugs have not been fully evaluated. Drugs which may potentiate the release of neutrophils, such as lithium should be used with caution.

Pregnancy & lactationView

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Pediatric usageView

Pediatric precautions: Filgrastim has been used in children 3 months to 18 years of age without unusual adverse effect. However, safety and efficacy of the drug in neonates or patients with autoimmune neutropenia of infancy have not been established.

Overdose effectsView

The possibility of Filgrastim acting as a growth factor for any tumor type and adverse effects of excessive neutrophils may occur in overdose of Filgrastim.

ReconstitutionView

Dilution of Filgrastim conc less than 5 mcg/ml is not recommended at any time. Filgrastim may be diluted in 5% dextrose as required

StorageView

Refrigerate at 2-8° C. Do not freeze.

Filazine

Diethylcarbamazine Citrate

Tablet 100 mg Allopathic Other Anti-protozoals

Indications

Toxocariasis

Indication detailsView

Diethylcarbamazine is indicated for Filariasis, Lymphatic filariasis, Pulmonary eosinophilia, Loiasis, Toxocariasis.

Therapeutic classView

Other Anti-protozoals

PharmacologyView

The mechanism of action of diethylcarbamazine is thought to involve sensitizing the microfilariae to phagocytosis. One study showed that diethylcarbamazine's activity against Brugia malayi microfilariae is dependent on inducible nitric-oxide synthase and the cyclooxygenase pathway. It confirmed the important role of the arachidonic acid metabolic pathway in diethylcarbamazine's mechanism of action in vivo and showes that in addition to its effects on the 5-lipoxygenase pathway, it targets the cyclooxygenase pathway and COX-1.

DosageView

Inital: 1 mg/kg/day, may increase to 6 mg/kg/day over 3 days, then maintain for 3 wk. Prophylaxis of loiasis 300 mg/wk.

Side effectsView

Fever, headache, vomiting, dizziness, drowsiness, nausea, chills.

Potentially Fatal: Severe hypersensitivity reactions may occur especially in the treatment of onchocerciasis where rare Mazzotti reaction characterised by rash, itching, headache, muscle and joint pains, tachycardia, postural hypotension may start within 2 hr of drug administration. Encephalitis and retinal haemorrhage.

ContraindicationsView

Pregnancy, hypersensitivity; lactation; infants, elderly or debilitated patients; impaired renal function; cardiac disease.

PrecautionsView

Patients with poor health.

Lactation: not known if excreted in breast milk

InteractionsView

There are no known drug interactions and none well documented.

Pregnancy & lactationView

Pregnancy Category- X. Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.