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Xaloplat

Oxaliplatin

IV Infusion 5 mg/ml Allopathic Cytotoxic Chemotherapy

Indications

Oesophageal cancer

Indication detailsView

Oxaliplatin, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for:

Adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
Treatment of advanced colorectal cancer.

Therapeutic classView

Cytotoxic Chemotherapy

PharmacologyView

Oxaliplatin, a platinum-containing complex similar to cisplatin, is an alkylating agent. After intracellular hydrolysis, the platinum compound binds to DNA forming cross-links which inhibit DNA replication and transcription, resulting in cell death.

DosageView

Intravenous (Adult)-

Adjuvant therapy in stage III colon cancer: In combination with fluorouracil/ leucovorin: 85 mg/m² every 2 wk for 12 cycles. Dose to be given by IV infusion over 2-6 hr, dissolved in 250-500 ml of glucose 5%, every 2 wk; given for 12 cycles. After recovery from toxicity, reduce dose to 75 mg/m². Administer before fluoropyrimidines.

Advanced colorectal cancer: In combination with fluorouracil/ leucovorin: 85 mg/m² every 2 wk until disease progression or unacceptable toxicity. Dose to be given by IV infusion over 2-6 hr, dissolved in 250-500 ml of glucose 5%, . After recovery from toxicity, reduce dose to 65 mg/m². Administer before fluoropyrimidines.

Side effectsView

Fatigue, fever, pain, headache, insomnia, nausea, diarrheoa, vomiting, abdominal pain, constipation, anorexia, stomatitis, anemia, thrombocytopenia, leukopenia, aspartate and alanine transaminases increased, total bilirubin increased, peripheral neuropathy, back pain, dyspnoea, cough, oedema, chest pain, peripheral oedema, flushing , thromboembolism, dizziness, rash, alopecia , hand-foot syndrome dehydration, hypokalaemia, dyspepsia, taste perversion, flatulence, mucositis, gastroesophageal reflux, dysphagia, dysuria, neutropenia, inj site reaction, rigors, arthralgia, abnormal lacrimation, serum creatinine increased, rhinitis, epistaxis, pharyngitis, pharyngolaryngeal dysesthesia, allergic reactions, hiccup.

ContraindicationsView

Pregnancy. Peripheral neuropathy with functional impairment. Severe renal impairment.

PrecautionsView

Should be administered under the supervision of an experienced cancer chemotherapy physician. Use appropriate precautions for handling and disposal. Monitor neurological status and dose should be reduced if symptoms are prolonged or severe. Monitor blood counts during treatment and courses should not be repeated until blood counts have recovered. Caution in elderly, moderate degrees of renal impairment. Avoid using aluminum-containing needles or IV admin sets that may come into contact with oxaliplatin as aluminum has been reported to cause degradation of platinum compounds. Lactation.

InteractionsView

May decrease plasma levels of digoxin. May increase risk of toxicity with nephrotoxic drugs. When administered as sequential infusions, taxane derivatives (docetaxel, paclitaxel) should be administered before oxaliplatin to limit myelosuppression and enhance efficacy.

Pregnancy & lactationView

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Pediatric usageView

Renal Impairment: Dose adjustment may be needed

Overdose effectsView

Extensions of known adverse reaction (e.g. thrombocytopenia, myelosuppression, nausea, vomiting, neurotoxicity, respiratory symptoms). Treatment is supportive.

ReconstitutionView

Reconstitute with 10 ml (for 50 mg vial) or 20 ml (for 100 mg vial) water for inj or 5% dextrose inj. Reconstituted solution must be further diluted with 250-500 ml of 5% dextrose inj before admin.

StorageView

Store intact vials at 15-30°C; do not freeze. Reconstituted solution: May store at 2-8°C for up to 24 hr. Diluted solutions: Stable up to 6 hr at 20-25°C or up to 24 hr under refrigeration at 2-8°C.

Xamic

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.

Xamic

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.

Xanax

Alprazolam

Tablet 0.5 mg Allopathic Benzodiazepine sedatives

Indications

Vestibular neuritis

Indication detailsView

Alprazolam is indicated in-

Anxiety disorder
Short term relief of anxiety
Anxiety associated with depression
Panic disorder, with or without agoraphobia.

Therapeutic classView

Benzodiazepine sedatives

PharmacologyView

Alprazolam is a triazole analog of the 1,4-benzodiazepine class of drugs. It is an anxiolytic with hypnotic and anticonvulsive properties. Alprazolam is presumed to produce its effects via interacting with the Gamma Aminobutyric Acid (GABA)- benzodiazepine receptor complex. Like all benzodiazepines, it causes a dose-related CNS depressant activity varying from mild impairment of task performance to hypnosis.

DosageView

Treatment should be initiated with a dose of 0.25 to 0.5 mg three times daily. Depending on the response, dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg/day. The maximum dose should not exceed 4 mg/day. Occasional patients with panic disorder may need as much as 10 mg a day to achieve a successful response and in these cases periodic reassessment and consideration of dosage adjustment is required.

Dosage should be individualized for maximum beneficial effect with the lowest possible dose. If side-effects occur at starting dose, dose may be lowered. When discontinuing therapy, dosage should be reduced gradually by no more than 0.5 mg every three days.

In elderly patients or in patients with advanced liver disease, the usual starting dose is 0.25 mg, two or three times daily and may be gradually increased if needed and tolerated.

Alprazolam 1 mg should be administered once daily, preferably in the morning by patients who are on multiple dosage regimens of Alprazolam 0.25/0.5 mg. The tablets should be taken intact, they should not be chewed, crushed, or broken.

Side effectsView

Side effects, if occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. The most frequent side effects are drowsiness and light-headedness. The other side effects, that may occur include depression, headache, confusion, dry mouth, constipation, etc.

PrecautionsView

Because Alprazolam may produce psychological and physical dependence, the increment of dose or abrupt discontinuation of Alprazolam therapy should not be done without the physician's advice. The duration of therapy must be determined by the physicians. Alprazolam should be administered with caution to patients with hepatic or renal disease, chronic pulmonary insufficiency, or sleep apnea.

InteractionsView

The CNS-depressant action of Alprazolam may be aggravated by concomitant use of other psychotropic drugs, anticonvulsants, antihistaminics, alcohol and oral ontraceptives.

Pregnancy & lactationView

Alprazolam has been categorized in pregnancy category D; that means, it should be avoided in pregnancy. Like other benzodiazepines, Alprazolam is assumed to be excreted in breast milk. Therefore, nursing should not be undertaken by mothers who must use Alprazolam.

Pediatric usageView

The safety and effectiveness of Alprazolam in individuals below 18 years of age have not been established.

Overdose effectsView

Manifestations of Alprazolam overdosage include somnolence, confusion, impaired coordination, diminished reflexes, and coma. In such cases of overdosage general supportive measures should be employed along with immediate gastric lavage.

StorageView

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

Xanax

Alprazolam

Tablet 0.25 mg Allopathic Benzodiazepine sedatives

Indications

Vestibular neuritis

Indication detailsView

Alprazolam is indicated in-

Anxiety disorder
Short term relief of anxiety
Anxiety associated with depression
Panic disorder, with or without agoraphobia.

Therapeutic classView

Benzodiazepine sedatives

PharmacologyView

Alprazolam is a triazole analog of the 1,4-benzodiazepine class of drugs. It is an anxiolytic with hypnotic and anticonvulsive properties. Alprazolam is presumed to produce its effects via interacting with the Gamma Aminobutyric Acid (GABA)- benzodiazepine receptor complex. Like all benzodiazepines, it causes a dose-related CNS depressant activity varying from mild impairment of task performance to hypnosis.

DosageView

Treatment should be initiated with a dose of 0.25 to 0.5 mg three times daily. Depending on the response, dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg/day. The maximum dose should not exceed 4 mg/day. Occasional patients with panic disorder may need as much as 10 mg a day to achieve a successful response and in these cases periodic reassessment and consideration of dosage adjustment is required.

Dosage should be individualized for maximum beneficial effect with the lowest possible dose. If side-effects occur at starting dose, dose may be lowered. When discontinuing therapy, dosage should be reduced gradually by no more than 0.5 mg every three days.

In elderly patients or in patients with advanced liver disease, the usual starting dose is 0.25 mg, two or three times daily and may be gradually increased if needed and tolerated.

Alprazolam 1 mg should be administered once daily, preferably in the morning by patients who are on multiple dosage regimens of Alprazolam 0.25/0.5 mg. The tablets should be taken intact, they should not be chewed, crushed, or broken.

Side effectsView

Side effects, if occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. The most frequent side effects are drowsiness and light-headedness. The other side effects, that may occur include depression, headache, confusion, dry mouth, constipation, etc.

PrecautionsView

Because Alprazolam may produce psychological and physical dependence, the increment of dose or abrupt discontinuation of Alprazolam therapy should not be done without the physician's advice. The duration of therapy must be determined by the physicians. Alprazolam should be administered with caution to patients with hepatic or renal disease, chronic pulmonary insufficiency, or sleep apnea.

InteractionsView

The CNS-depressant action of Alprazolam may be aggravated by concomitant use of other psychotropic drugs, anticonvulsants, antihistaminics, alcohol and oral ontraceptives.

Pregnancy & lactationView

Alprazolam has been categorized in pregnancy category D; that means, it should be avoided in pregnancy. Like other benzodiazepines, Alprazolam is assumed to be excreted in breast milk. Therefore, nursing should not be undertaken by mothers who must use Alprazolam.

Pediatric usageView

The safety and effectiveness of Alprazolam in individuals below 18 years of age have not been established.

Overdose effectsView

Manifestations of Alprazolam overdosage include somnolence, confusion, impaired coordination, diminished reflexes, and coma. In such cases of overdosage general supportive measures should be employed along with immediate gastric lavage.

StorageView

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

Xanbac

Baclofen

Tablet 10 mg Allopathic Centrally acting Skeletal Muscle Relaxants

Indications

Trigeminal neuralgia

Indication detailsView

Baclofen is indicated in-

spasticity resulting from multiple sclerosis
flexor spasms and concomitant pain, clonus and muscular rigidity
skeletal muscle spasm resulting from rheumatic disorders
spinal cord injuries and other spinal cord diseases
cerebrovascular accidents or neoplastic or degenerative brain disease

Therapeutic classView

Centrally acting Skeletal Muscle Relaxants

PharmacologyView

Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABA_Breceptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.

DosageView

Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.

Children <10 years: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-

12 month-2 years: 10-20 mg (10-20 ml)
2 years-6 years: 20-30 mg (20-30 ml)
6 years-10 years: 30-60 mg (30-60 ml)

Side effectsView

The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue.

Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression.
Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.

ContraindicationsView

Baclofen is contraindicated in patients with hypersensitivity to any component of this product.

PrecautionsView

Lower doses (approximately 5 mg per day) should be used for patients with impaired renal function or those undergoing chronic haemodialysis.
Patients suffering not only from spasticity but also from psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously and closely monitored as exacerbations of these disorders may occur.
In patients with epilepsy and muscle spasticity, Baclofen may be used under appropriate supervision and provided that adequate anticonvulsive therapy is continued. Lowering of the convulsion threshold may occur and seizures have been reported after the cessation of Baclofen therapy or with overdose.
Baclofen should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure.
Careful monitoring of respiratory and cardiovascular function is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.
During treatment with Baclofen, neurogenic disturbances affecting emptying of the bladder may improve. However in patients with preexisting sphincter hypertonia, acute retention of urine may occur. Baclofen should be used with caution in these circumstances.
Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerance to the medicine.
Appropriate laboratory tests should be performed periodically in patients with hepatic diseases or diabetes mellitus to ensure that no medicine induced changes in these underlying diseases have occurred.

InteractionsView

Increased sedation may occur if Baclofen is taken with agents acting on the central nervous system, alcohol or synthetic opiates. The risk of respiratory depression is also increased.
Combined treatment with Baclofen and antihypertensives is likely to increase the fall in blood pressure; therefore the dosage of antihypertensive medication should be adjusted accordingly.
The concomitant administration of Baclofen and tricyclic antidepressants may potentiate the pharmacological effects of Baclofen resulting in pronounced muscular hypotonia.
In patients with Parkinsons disease receiving treatment with Baclofen and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation.
The concurrent use of MAO inhibitors and Baclofen may result in increased CNS depressant effects. Caution is advised and the dosage of one or both agents should be adjusted accordingly.
Caution should be exercised when administering Baclofen and magnesium sulphate or other neuromuscular blocking agents since a synergistic effect may theoretically occur.

Pregnancy & lactationView

Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.

Overdose effectsView

Gastric lavage is important in case of severe overdose.

StorageView

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

Xanide

Nitazoxanide

Powder for Suspension 100 mg/5 ml Allopathic Anti-diarrhoeal Antiprotozoal

Indications

Giardiasis

Indication detailsView

Nitazoxanide is indicated for the treatment of diarrhea caused by Cryptosporidium parvum, Giardia lamblia and Entamoeba histolytica.

Therapeutic classView

Anti-diarrhoeal Antiprotozoal

PharmacologyView

Nitazoxanide is a synthetic antiprotozoal agent for oral administration. The antiprotozoal activity of Nitazoxanide is believed to be interference with the Pyruvate Ferredoxin Oxido Reductase (PFOR) enzyme-dependant electron transfer reaction. This reaction is essential for anaerobic energy metabolism of the protozoa. Nitazoxanide and its metabolites, tizoxanid are active in vitro in inhibiting the growth of sporozoites and oocyst of Cryptosporidium parvum and trophozoites of Giardia lamblia.

DosageView

Age 1-3 years: 1 tea-spoonfull or 5 ml suspension every 12 hours for 3 days.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.

It is recommended to be administered with food.

Side effectsView

The most frequent side effects, reported by Nitazoxanide are abdominal pain, vomiting and headache. These side effects are typically mild and transient in nature. Very rare side effects include- nausea, anorexia, flatulence, increased appetite, enlarged salivary glands, increased creatinine & SGPT level, pruritus, rhinitis, sweating, dizziness, discolored urine etc.

ContraindicationsView

It is contraindicated in patients with known hypersensitivity to Nitazoxanide or any components of the preparation.

PrecautionsView

Nitazoxanide must be administered with caution to patients with hepatic & biliary disease and to patients with renal disease.

InteractionsView

It is highly bound to plasma protein. Therefore, caution should be exercised when administering Nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic index.

Pregnancy & lactationView

US FDA pregnancy category of Nitazoxanide 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. Nitazoxanide have been shown to be excreted in human milk. So, caution should be exercised when Nitazoxanide is administered during lactation.

StorageView

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

Xanide

Nitazoxanide

Tablet 500 mg Allopathic Anti-diarrhoeal Antiprotozoal

Indications

Giardiasis

Indication detailsView

Nitazoxanide is indicated for the treatment of diarrhea caused by Cryptosporidium parvum, Giardia lamblia and Entamoeba histolytica.

Therapeutic classView

Anti-diarrhoeal Antiprotozoal

PharmacologyView

Nitazoxanide is a synthetic antiprotozoal agent for oral administration. The antiprotozoal activity of Nitazoxanide is believed to be interference with the Pyruvate Ferredoxin Oxido Reductase (PFOR) enzyme-dependant electron transfer reaction. This reaction is essential for anaerobic energy metabolism of the protozoa. Nitazoxanide and its metabolites, tizoxanid are active in vitro in inhibiting the growth of sporozoites and oocyst of Cryptosporidium parvum and trophozoites of Giardia lamblia.

DosageView

Age 1-3 years: 1 tea-spoonfull or 5 ml suspension every 12 hours for 3 days.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.

It is recommended to be administered with food.

Side effectsView

The most frequent side effects, reported by Nitazoxanide are abdominal pain, vomiting and headache. These side effects are typically mild and transient in nature. Very rare side effects include- nausea, anorexia, flatulence, increased appetite, enlarged salivary glands, increased creatinine & SGPT level, pruritus, rhinitis, sweating, dizziness, discolored urine etc.

ContraindicationsView

It is contraindicated in patients with known hypersensitivity to Nitazoxanide or any components of the preparation.

PrecautionsView

Nitazoxanide must be administered with caution to patients with hepatic & biliary disease and to patients with renal disease.

InteractionsView

It is highly bound to plasma protein. Therefore, caution should be exercised when administering Nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic index.

Pregnancy & lactationView

US FDA pregnancy category of Nitazoxanide 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. Nitazoxanide have been shown to be excreted in human milk. So, caution should be exercised when Nitazoxanide is administered during lactation.

StorageView

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

Xanita

Nitazoxanide

Powder for Suspension 100 mg/5 ml Allopathic Anti-diarrhoeal Antiprotozoal

Indications

Giardiasis

Indication detailsView

Nitazoxanide is indicated for the treatment of diarrhea caused by Cryptosporidium parvum, Giardia lamblia and Entamoeba histolytica.

Therapeutic classView

Anti-diarrhoeal Antiprotozoal

PharmacologyView

Nitazoxanide is a synthetic antiprotozoal agent for oral administration. The antiprotozoal activity of Nitazoxanide is believed to be interference with the Pyruvate Ferredoxin Oxido Reductase (PFOR) enzyme-dependant electron transfer reaction. This reaction is essential for anaerobic energy metabolism of the protozoa. Nitazoxanide and its metabolites, tizoxanid are active in vitro in inhibiting the growth of sporozoites and oocyst of Cryptosporidium parvum and trophozoites of Giardia lamblia.

DosageView

Age 1-3 years: 1 tea-spoonfull or 5 ml suspension every 12 hours for 3 days.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.

It is recommended to be administered with food.

Side effectsView

The most frequent side effects, reported by Nitazoxanide are abdominal pain, vomiting and headache. These side effects are typically mild and transient in nature. Very rare side effects include- nausea, anorexia, flatulence, increased appetite, enlarged salivary glands, increased creatinine & SGPT level, pruritus, rhinitis, sweating, dizziness, discolored urine etc.

ContraindicationsView

It is contraindicated in patients with known hypersensitivity to Nitazoxanide or any components of the preparation.

PrecautionsView

Nitazoxanide must be administered with caution to patients with hepatic & biliary disease and to patients with renal disease.

InteractionsView

It is highly bound to plasma protein. Therefore, caution should be exercised when administering Nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic index.

Pregnancy & lactationView

US FDA pregnancy category of Nitazoxanide 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. Nitazoxanide have been shown to be excreted in human milk. So, caution should be exercised when Nitazoxanide is administered during lactation.

StorageView

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

Xanita

Nitazoxanide

Tablet 500 mg Allopathic Anti-diarrhoeal Antiprotozoal

Indications

Giardiasis

Indication detailsView

Nitazoxanide is indicated for the treatment of diarrhea caused by Cryptosporidium parvum, Giardia lamblia and Entamoeba histolytica.

Therapeutic classView

Anti-diarrhoeal Antiprotozoal

PharmacologyView

Nitazoxanide is a synthetic antiprotozoal agent for oral administration. The antiprotozoal activity of Nitazoxanide is believed to be interference with the Pyruvate Ferredoxin Oxido Reductase (PFOR) enzyme-dependant electron transfer reaction. This reaction is essential for anaerobic energy metabolism of the protozoa. Nitazoxanide and its metabolites, tizoxanid are active in vitro in inhibiting the growth of sporozoites and oocyst of Cryptosporidium parvum and trophozoites of Giardia lamblia.

DosageView

Age 1-3 years: 1 tea-spoonfull or 5 ml suspension every 12 hours for 3 days.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.

It is recommended to be administered with food.

Side effectsView

The most frequent side effects, reported by Nitazoxanide are abdominal pain, vomiting and headache. These side effects are typically mild and transient in nature. Very rare side effects include- nausea, anorexia, flatulence, increased appetite, enlarged salivary glands, increased creatinine & SGPT level, pruritus, rhinitis, sweating, dizziness, discolored urine etc.

ContraindicationsView

It is contraindicated in patients with known hypersensitivity to Nitazoxanide or any components of the preparation.

PrecautionsView

Nitazoxanide must be administered with caution to patients with hepatic & biliary disease and to patients with renal disease.

InteractionsView

It is highly bound to plasma protein. Therefore, caution should be exercised when administering Nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic index.

Pregnancy & lactationView

US FDA pregnancy category of Nitazoxanide 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. Nitazoxanide have been shown to be excreted in human milk. So, caution should be exercised when Nitazoxanide is administered during lactation.

StorageView

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

Xanra

Dexlansoprazole

Capsule (Delayed Release) 60 mg Allopathic Proton Pump Inhibitor

Indications

Oesophagitis

Indication detailsView

Healing of Erosive Esophagitis: Dexlansoprazole is indicated for the healing of all grades of erosive esophagitis (EE) for up to 8 weeks.

Maintenance of Healed Erosive Esophagitis: Dexlansoprazole is indicated to maintain healing of EE and relief of heartburn for up to 6 months.

Symptomatic Non-Erosive Gastroesophageal Reflux Disease: Dexlansoprazole is indicated for the treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD) for 4 weeks.

Therapeutic classView

Proton Pump Inhibitor

PharmacologyView

Dexlansoprazole delayed-release capsule is a Proton Pump Inhibitor (PPI) which suppresses gastric acid secretion by specific inhibition of the (H⁺/K⁺)-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Dexlansoprazole blocks the final step of acid production. It is the R-enantiomer of lansoprazole (A racemic mixture of the R- and S-enantiomers). Dexlansoprazole is supplied as a Dual Delayed Release (DDR) formulation in a capsule for oral administration. This capsule contains a mixture of two types of enteric coated granules with different pH-dependent dissolution profiles. The dual delayed release formulation in dexlansoprazole, plasma concentration-time profile with two distinct peaks; the first peak occurs 1 to 2 hours after administration, followed by a second peak within 4 to 5 hours. After oral administration, mean C_max and AUC value of Dexlansoprazole increased approximately dose proportionally. Dexlansoprazole is extensively metabolized in the liver and excreated by urine.

DosageView

Dexlansoprazole dosing recommendations-

Maintenance of Healed erosive esophagitis and relief of heartburn: 30 mg Once daily
Symptomatic Non-Erosive GERD: 30 mg Once daily for 4 weeks
Healing of erosive esophagitis: 60 mg Once daily for up to 8 weeks

AdministrationView

Dexlansoprazole can be taken without regard to food. It should be swallowed whole.

Alternatively, Dexlansoprazole capsules can be administered as follows:

Open capsule
Sprinkle intact granules on one tablespoon
Swallow immediately.

Granules should not be chewed.

If a capsule is missed at its usual time, it should be taken as soon as possible. But if it is too close to the time of the next dose, only the prescribed dose should be taken at the appointed time. A double dose should not be taken.

Side effectsView

Common side effects: Diarrhea, abdominal pain, nausea, vomiting & flatulence.

ContraindicationsView

Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.

PrecautionsView

Gastric Malignancy, Clostridium difficile Associated Diarrhea, Bone fracture, Hypomagnesemia, and concomitant use of Dexlansoprazole with Methotrexate.

InteractionsView

With medicine: Atazanavir, Warfarin, Tacrolimus, Clopidogrel & Methotrexate. With food & others: No data available.

Pregnancy & lactationView

Pregnancy Category B. There is no adequate and well-controlled studies with Dexlansoprazole in pregnant women. There is no adequate and well-controlled studies with Dexlansoprazole in Lactating mother.

Pediatric usageView

Use in children & adolescents: Safety and effectiveness of Dexlansoprazole in patients below 12 years age have not been established.

Geriatric use: No dose adjustment is necessary for elderly patients.

Renal impairment: No dose adjustment of Dexlansoprazole is necessary for patients with renal
impairment.

Hepatic impairment: No dose adjustment for Dexlansoprazole is necessary for patients with mild hepatic impairment. A maximum daily dose of Dexlansoprazole 30 mg should be considered for patients with moderate hepatic impairment.

Overdose effectsView

There have been no reports of a significant overdose of Dexlansoprazole. Multiple doses of Dexlansoprazole 120 mg and a single dose of Dexlansoprazole 300 mg did not result in death or other severe adverse events.

StorageView

Store below 30°C temperature & in a dry place, protected from light. Keep all medicines out of reach of children.

Xanra

Dexlansoprazole

Capsule (Delayed Release) 30 mg Allopathic Proton Pump Inhibitor

Indications

Oesophagitis

Indication detailsView

Healing of Erosive Esophagitis: Dexlansoprazole is indicated for the healing of all grades of erosive esophagitis (EE) for up to 8 weeks.

Maintenance of Healed Erosive Esophagitis: Dexlansoprazole is indicated to maintain healing of EE and relief of heartburn for up to 6 months.

Symptomatic Non-Erosive Gastroesophageal Reflux Disease: Dexlansoprazole is indicated for the treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD) for 4 weeks.

Therapeutic classView

Proton Pump Inhibitor

PharmacologyView

Dexlansoprazole delayed-release capsule is a Proton Pump Inhibitor (PPI) which suppresses gastric acid secretion by specific inhibition of the (H⁺/K⁺)-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Dexlansoprazole blocks the final step of acid production. It is the R-enantiomer of lansoprazole (A racemic mixture of the R- and S-enantiomers). Dexlansoprazole is supplied as a Dual Delayed Release (DDR) formulation in a capsule for oral administration. This capsule contains a mixture of two types of enteric coated granules with different pH-dependent dissolution profiles. The dual delayed release formulation in dexlansoprazole, plasma concentration-time profile with two distinct peaks; the first peak occurs 1 to 2 hours after administration, followed by a second peak within 4 to 5 hours. After oral administration, mean C_max and AUC value of Dexlansoprazole increased approximately dose proportionally. Dexlansoprazole is extensively metabolized in the liver and excreated by urine.

DosageView

Dexlansoprazole dosing recommendations-

Maintenance of Healed erosive esophagitis and relief of heartburn: 30 mg Once daily
Symptomatic Non-Erosive GERD: 30 mg Once daily for 4 weeks
Healing of erosive esophagitis: 60 mg Once daily for up to 8 weeks

AdministrationView

Dexlansoprazole can be taken without regard to food. It should be swallowed whole.

Alternatively, Dexlansoprazole capsules can be administered as follows:

Open capsule
Sprinkle intact granules on one tablespoon
Swallow immediately.

Granules should not be chewed.

If a capsule is missed at its usual time, it should be taken as soon as possible. But if it is too close to the time of the next dose, only the prescribed dose should be taken at the appointed time. A double dose should not be taken.

Side effectsView

Common side effects: Diarrhea, abdominal pain, nausea, vomiting & flatulence.

ContraindicationsView

Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.

PrecautionsView

Gastric Malignancy, Clostridium difficile Associated Diarrhea, Bone fracture, Hypomagnesemia, and concomitant use of Dexlansoprazole with Methotrexate.

InteractionsView

With medicine: Atazanavir, Warfarin, Tacrolimus, Clopidogrel & Methotrexate. With food & others: No data available.

Pregnancy & lactationView

Pregnancy Category B. There is no adequate and well-controlled studies with Dexlansoprazole in pregnant women. There is no adequate and well-controlled studies with Dexlansoprazole in Lactating mother.

Pediatric usageView

Use in children & adolescents: Safety and effectiveness of Dexlansoprazole in patients below 12 years age have not been established.

Geriatric use: No dose adjustment is necessary for elderly patients.

Renal impairment: No dose adjustment of Dexlansoprazole is necessary for patients with renal
impairment.

Hepatic impairment: No dose adjustment for Dexlansoprazole is necessary for patients with mild hepatic impairment. A maximum daily dose of Dexlansoprazole 30 mg should be considered for patients with moderate hepatic impairment.

Overdose effectsView

There have been no reports of a significant overdose of Dexlansoprazole. Multiple doses of Dexlansoprazole 120 mg and a single dose of Dexlansoprazole 300 mg did not result in death or other severe adverse events.

StorageView

Store below 30°C temperature & in a dry place, protected from light. Keep all medicines out of reach of children.

Xantid

Ranitidine Hydrochloride

IM/IV Injection 50 mg/2 ml Allopathic H2 receptor antagonist

Indications

Zollinger-Ellison syndrome

Indication detailsView

Ranitidine is indicated in:

Treatment of active duodenal ulcer
Benign gastric ulcer
Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
Post operative stress ulcer.
Zollinger-Ellison Syndrome.
Gastroesophageal reflux disease (GERD).
Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
Recurrent haemorrhage in patients with bleeding peptic ulcer.
Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.

Therapeutic classView

H2 receptor antagonist

PharmacologyView

Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.

DosageView

Ranitidine Tablet & Syrup:

Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.

Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.

Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.

Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.

Maintenance: 150 mg at night for preventing recurrences.

Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.

Ranitidine IV injection & IV Infusion:

Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.

In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.

Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.

Side effectsView

Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.

ContraindicationsView

Patients hypersensitive to Ranitidine

PrecautionsView

Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.

InteractionsView

Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.

Pregnancy & lactationView

Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.

Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.

Pediatric usageView

Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.

Overdose effectsView

Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.

ReconstitutionView

Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.

Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

StorageView

Store in a cool and dry place. protect from light.

Xantid

Ranitidine Hydrochloride

Tablet 150 mg Allopathic H2 receptor antagonist

Indications

Zollinger-Ellison syndrome

Indication detailsView

Ranitidine is indicated in:

Treatment of active duodenal ulcer
Benign gastric ulcer
Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
Post operative stress ulcer.
Zollinger-Ellison Syndrome.
Gastroesophageal reflux disease (GERD).
Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
Recurrent haemorrhage in patients with bleeding peptic ulcer.
Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.

Therapeutic classView

H2 receptor antagonist

PharmacologyView

Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.

DosageView

Ranitidine Tablet & Syrup:

Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.

Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.

Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.

Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.

Maintenance: 150 mg at night for preventing recurrences.

Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.

Ranitidine IV injection & IV Infusion:

Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.

In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.

Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.

Side effectsView

Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.

ContraindicationsView

Patients hypersensitive to Ranitidine

PrecautionsView

Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.

InteractionsView

Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.

Pregnancy & lactationView

Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.

Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.

Pediatric usageView

Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.

Overdose effectsView

Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.

ReconstitutionView

Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.

Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

StorageView

Store in a cool and dry place. protect from light.

Xanuric

Febuxostat

Tablet 120 mg Allopathic Drugs used in Gout

Indications

Uric acid nephropathy

Indication detailsView

Febuxostat is indicated for the chronic management of hyperuricemia in patients with gout. Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia.

Therapeutic classView

Drugs used in Gout

PharmacologyView

Febuxostat is a non-purine, selective xanthine oxidase (XO) inhibitor. It decreases serum uric acid level by inhibiting xanthine oxidase, which is responsible for uric acid production. Xanthine oxidase breaks down hypoxanthine to xanthine and thus to uric acid. Febuxostat is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.

DosageView

Febuxostat is recommended at 40 mg or 80 mg once daily. The recommended starting dose of Febuxostat is 40 mg once daily. For patients who do not achieve a serum uric acid less than 6 mg /dL after 2 weeks with 40 mg, Febuxostat 80 mg is recommended. Febuxostat can be administered without regard to food or antacid use. No dose adjustment is necessary when administering Febuxostat to patients with mild to moderate renal or hepatic impairment.

Side effectsView

The most common adverse events associated with the use of Febuxostat may include liver function abnormalities, nausea, arthralgia, and rash.

ContraindicationsView

Febuxostat is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.

PrecautionsView

Gout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Febuxostat. If a gout flare occurs during treatment, Febuxostat need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months.

Cardiovascular Events: A higher rate of cardiovascular thromboembolic events was observed in patients treated with febuxostat than allopurinol in clinical trials. Monitor for signs and symptoms of MI and stroke.

Liver Enzyme Elevation: Transaminase elevations have been observed in febuxostat -treated patients. Monitor liver function tests periodically.

InteractionsView

Concomitant administration of Febuxostat with azathioprine, mercaptopurine or theophylline could increase plasma concentrations of these drugs resulting in severe toxicity.

Pregnancy & lactationView

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Febuxostat should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Caution should be exercised when Febuxostat is administered to a nursing woman.

Pediatric usageView

Pediatric Use: Safety and effectiveness in pediatric patients under 18 years of age have not been established

Overdose effectsView

Febustat was studied in healthy subjects in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities.

StorageView

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

Xanuric

Febuxostat

Tablet 80 mg Allopathic Drugs used in Gout

Indications

Uric acid nephropathy

Indication detailsView

Febuxostat is indicated for the chronic management of hyperuricemia in patients with gout. Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia.

Therapeutic classView

Drugs used in Gout

PharmacologyView

Febuxostat is a non-purine, selective xanthine oxidase (XO) inhibitor. It decreases serum uric acid level by inhibiting xanthine oxidase, which is responsible for uric acid production. Xanthine oxidase breaks down hypoxanthine to xanthine and thus to uric acid. Febuxostat is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.

DosageView

Febuxostat is recommended at 40 mg or 80 mg once daily. The recommended starting dose of Febuxostat is 40 mg once daily. For patients who do not achieve a serum uric acid less than 6 mg /dL after 2 weeks with 40 mg, Febuxostat 80 mg is recommended. Febuxostat can be administered without regard to food or antacid use. No dose adjustment is necessary when administering Febuxostat to patients with mild to moderate renal or hepatic impairment.

Side effectsView

The most common adverse events associated with the use of Febuxostat may include liver function abnormalities, nausea, arthralgia, and rash.

ContraindicationsView

Febuxostat is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.

PrecautionsView

Gout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Febuxostat. If a gout flare occurs during treatment, Febuxostat need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months.

Cardiovascular Events: A higher rate of cardiovascular thromboembolic events was observed in patients treated with febuxostat than allopurinol in clinical trials. Monitor for signs and symptoms of MI and stroke.

Liver Enzyme Elevation: Transaminase elevations have been observed in febuxostat -treated patients. Monitor liver function tests periodically.

InteractionsView

Concomitant administration of Febuxostat with azathioprine, mercaptopurine or theophylline could increase plasma concentrations of these drugs resulting in severe toxicity.

Pregnancy & lactationView

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Febuxostat should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Caution should be exercised when Febuxostat is administered to a nursing woman.

Pediatric usageView

Pediatric Use: Safety and effectiveness in pediatric patients under 18 years of age have not been established

Overdose effectsView

Febustat was studied in healthy subjects in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities.

StorageView

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

Xanuric

Febuxostat

Tablet 40 mg Allopathic Drugs used in Gout

Indications

Uric acid nephropathy

Indication detailsView

Febuxostat is indicated for the chronic management of hyperuricemia in patients with gout. Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia.

Therapeutic classView

Drugs used in Gout

PharmacologyView

Febuxostat is a non-purine, selective xanthine oxidase (XO) inhibitor. It decreases serum uric acid level by inhibiting xanthine oxidase, which is responsible for uric acid production. Xanthine oxidase breaks down hypoxanthine to xanthine and thus to uric acid. Febuxostat is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.

DosageView

Febuxostat is recommended at 40 mg or 80 mg once daily. The recommended starting dose of Febuxostat is 40 mg once daily. For patients who do not achieve a serum uric acid less than 6 mg /dL after 2 weeks with 40 mg, Febuxostat 80 mg is recommended. Febuxostat can be administered without regard to food or antacid use. No dose adjustment is necessary when administering Febuxostat to patients with mild to moderate renal or hepatic impairment.

Side effectsView

The most common adverse events associated with the use of Febuxostat may include liver function abnormalities, nausea, arthralgia, and rash.

ContraindicationsView

Febuxostat is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.

PrecautionsView

Gout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Febuxostat. If a gout flare occurs during treatment, Febuxostat need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months.

Cardiovascular Events: A higher rate of cardiovascular thromboembolic events was observed in patients treated with febuxostat than allopurinol in clinical trials. Monitor for signs and symptoms of MI and stroke.

Liver Enzyme Elevation: Transaminase elevations have been observed in febuxostat -treated patients. Monitor liver function tests periodically.

InteractionsView

Concomitant administration of Febuxostat with azathioprine, mercaptopurine or theophylline could increase plasma concentrations of these drugs resulting in severe toxicity.

Pregnancy & lactationView

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Febuxostat should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Caution should be exercised when Febuxostat is administered to a nursing woman.

Pediatric usageView

Pediatric Use: Safety and effectiveness in pediatric patients under 18 years of age have not been established

Overdose effectsView

Febustat was studied in healthy subjects in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities.

StorageView

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

Xardin

Ranitidine Hydrochloride

Tablet 150 mg Allopathic H2 receptor antagonist

Indications

Zollinger-Ellison syndrome

Indication detailsView

Ranitidine is indicated in:

Treatment of active duodenal ulcer
Benign gastric ulcer
Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
Post operative stress ulcer.
Zollinger-Ellison Syndrome.
Gastroesophageal reflux disease (GERD).
Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
Recurrent haemorrhage in patients with bleeding peptic ulcer.
Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.

Therapeutic classView

H2 receptor antagonist

PharmacologyView

Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.

DosageView

Ranitidine Tablet & Syrup:

Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.

Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.

Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.

Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.

Maintenance: 150 mg at night for preventing recurrences.

Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.

Ranitidine IV injection & IV Infusion:

Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.

In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.

Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.

Side effectsView

Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.

ContraindicationsView

Patients hypersensitive to Ranitidine

PrecautionsView

Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.

InteractionsView

Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.

Pregnancy & lactationView

Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.

Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.

Pediatric usageView

Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.

Overdose effectsView

Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.

ReconstitutionView

Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.

Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

StorageView

Store in a cool and dry place. protect from light.

Xarelta

Rivaroxaban

Tablet 20 mg Allopathic Oral Anti-coagulants

Indications

Stroke

Indication detailsView

Rivaroxaban 2.5 mg:

For the prevention of atherothrombotic events in adult patients after an Acute Coronary Syndrome (ACS) with elevated cardiac biomarkers (Troponin or CK-MB). It is co-administered with Aspirin alone or with Aspirin plus Clopidogrel orTidopidine.

Rivaroxaban 10-20 mg:

To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
Deep vein thrombosis (DVT) & pulmonary embolism (PE) and reduction in the risk of recurrence of DVT and of PE
For the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery

Therapeutic classView

Oral Anti-coagulants

PharmacologyView

Rivaroxaban is a highly selective direct factor Xa inhibitor. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibits thrombin formation. Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated.

DosageView

Rivaroxaban 2.5 mg:

The recommended dose: 2.5 mg twice daily. Patients should also take a daily dose of 75-100 mg Aspirin or a daily dose of 75-100 mg Aspirin in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine.

Rivaroxaban 10-20 mg:

Nonvalvular Atrial Fibrillation: For patients with Creatinin Clearance >50 mL/min: 20 mg orally, once daily with the evening meal. For patients with Creatinin Clearance 15-50 ml/min: 15 mg orally, once daily with the evening meal.
Treatment of DVT & PE: 15 mg orally twice daily with food for the first 21 days for the initial treatment of acute DVT or PE. After the initial treatment period, 20 mg orally once daily with food for the remaining treatment.
Prevention in the risk of recurrence of DVT and of PE: 20 mg once daily with food.
Prophylaxis of DVT following Hip replacement surgery: 10 mg once daily for 35 days.
Prophylaxis of DVT following knee replacement surgery: 10 mg once daily for 12 days.

May be taken with or without food.

Side effectsView

The most common side effects of Rivaroxaban have increased chance of bleeding, spinal or epidural hematoma and increased risk of stroke after discontinuation in nonvalvular atrial fibrillation.

ContraindicationsView

It is contraindicated in patients with known hypersensitivity of Rivaroxaban or any of the excipients of the product. It is also contraindicated in patients with active pathological bleeding.

PrecautionsView

Early discontinuation of Rivaroxaban, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. Rivaroxaban increases the risk of bleeding that can be fatal in presence of following risk factors- bleeding disorders, uncontrolled severe arterial hypertension, gastrointestinal disease (e.g., inflammatory bowel disease, oesophagitis, gastritis and gastroesophageal reflux disease), vascular retinopathy, bronchiectasis, history of pulmonary bleeding. Signs or symptoms of neurological impairment should be monitored in case of neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture as epidural or spinal hematoma can occur. Rivaroxaban is not recommended in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.

InteractionsView

Concomitant use with drugs that are combined P-gp and CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin, erythromycin, fluconazole, diltiazem, verapamil, dronedarone) increases in Rivaroxaban exposure and pharmacodynamic effects (i.e., factor Xa inhibition and PT prolongation), that’s why should be avoided. Co-administration of Rivaroxaban with a combined P-gp and strong CYP3A4 inducer (e.g., rifampicin, phenytoin, carbamazepine) decreases the efficacy of Rivaroxaban and also should be avoided. The concomitant use of other drugs like anti-platelet agents, heparin, fibrinolytic therapy, NSAIDs may cause an increased risk of bleeding.

Pregnancy & lactationView

Rivaroxaban is a pregnancy category C drug. There are no adequate or well-controlled studies of Rivaroxaban in pregnant women, and dosing for pregnant women has not been established. It is not known if Rivaroxaban is excreted in human milk. The safety and efficacy of Rivaroxaban has not been established in breastfeeding women.

Overdose effectsView

Overdose of Rivaroxaban may lead to hemorrhage. Rivaroxaban systemic exposure is not further increased at single doses >50 mg due to limited absorption. A specific antidote for Rivaroxaban is not available. The use of activated charcoal to reduce absorption in case of Rivaroxaban overdose may be considered. Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products.

StorageView

Store in a cool (below 30°C) & dry place protected from light. Keep away from the reach of children.

Xarelta

Rivaroxaban

Tablet 15 mg Allopathic Oral Anti-coagulants

Indications

Stroke

Indication detailsView

Rivaroxaban 2.5 mg:

For the prevention of atherothrombotic events in adult patients after an Acute Coronary Syndrome (ACS) with elevated cardiac biomarkers (Troponin or CK-MB). It is co-administered with Aspirin alone or with Aspirin plus Clopidogrel orTidopidine.

Rivaroxaban 10-20 mg:

To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
Deep vein thrombosis (DVT) & pulmonary embolism (PE) and reduction in the risk of recurrence of DVT and of PE
For the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery

Therapeutic classView

Oral Anti-coagulants

PharmacologyView

Rivaroxaban is a highly selective direct factor Xa inhibitor. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibits thrombin formation. Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated.

DosageView

Rivaroxaban 2.5 mg:

The recommended dose: 2.5 mg twice daily. Patients should also take a daily dose of 75-100 mg Aspirin or a daily dose of 75-100 mg Aspirin in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine.

Rivaroxaban 10-20 mg:

Nonvalvular Atrial Fibrillation: For patients with Creatinin Clearance >50 mL/min: 20 mg orally, once daily with the evening meal. For patients with Creatinin Clearance 15-50 ml/min: 15 mg orally, once daily with the evening meal.
Treatment of DVT & PE: 15 mg orally twice daily with food for the first 21 days for the initial treatment of acute DVT or PE. After the initial treatment period, 20 mg orally once daily with food for the remaining treatment.
Prevention in the risk of recurrence of DVT and of PE: 20 mg once daily with food.
Prophylaxis of DVT following Hip replacement surgery: 10 mg once daily for 35 days.
Prophylaxis of DVT following knee replacement surgery: 10 mg once daily for 12 days.

May be taken with or without food.

Side effectsView

The most common side effects of Rivaroxaban have increased chance of bleeding, spinal or epidural hematoma and increased risk of stroke after discontinuation in nonvalvular atrial fibrillation.

ContraindicationsView

It is contraindicated in patients with known hypersensitivity of Rivaroxaban or any of the excipients of the product. It is also contraindicated in patients with active pathological bleeding.

PrecautionsView

Early discontinuation of Rivaroxaban, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. Rivaroxaban increases the risk of bleeding that can be fatal in presence of following risk factors- bleeding disorders, uncontrolled severe arterial hypertension, gastrointestinal disease (e.g., inflammatory bowel disease, oesophagitis, gastritis and gastroesophageal reflux disease), vascular retinopathy, bronchiectasis, history of pulmonary bleeding. Signs or symptoms of neurological impairment should be monitored in case of neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture as epidural or spinal hematoma can occur. Rivaroxaban is not recommended in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.

InteractionsView

Concomitant use with drugs that are combined P-gp and CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin, erythromycin, fluconazole, diltiazem, verapamil, dronedarone) increases in Rivaroxaban exposure and pharmacodynamic effects (i.e., factor Xa inhibition and PT prolongation), that’s why should be avoided. Co-administration of Rivaroxaban with a combined P-gp and strong CYP3A4 inducer (e.g., rifampicin, phenytoin, carbamazepine) decreases the efficacy of Rivaroxaban and also should be avoided. The concomitant use of other drugs like anti-platelet agents, heparin, fibrinolytic therapy, NSAIDs may cause an increased risk of bleeding.

Pregnancy & lactationView

Rivaroxaban is a pregnancy category C drug. There are no adequate or well-controlled studies of Rivaroxaban in pregnant women, and dosing for pregnant women has not been established. It is not known if Rivaroxaban is excreted in human milk. The safety and efficacy of Rivaroxaban has not been established in breastfeeding women.

Overdose effectsView

Overdose of Rivaroxaban may lead to hemorrhage. Rivaroxaban systemic exposure is not further increased at single doses >50 mg due to limited absorption. A specific antidote for Rivaroxaban is not available. The use of activated charcoal to reduce absorption in case of Rivaroxaban overdose may be considered. Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products.

StorageView

Store in a cool (below 30°C) & dry place protected from light. Keep away from the reach of children.