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Drugs for Infertility

Clomiphene has mainly antiestrogenic effects and some estrogenic effects. The mechanism in stimulating ovulation is unknown but is believed to be related to its antiestrogenic properties. By clomiphene competing with estrogen for binding sites at the hypothalamic level, the gonadotropins, follicle-stimulating hormone (FSH) and luteinizing hormone (LH), secretion is increased, which results in ovarian follicle maturation, followed by the preovulatory LH surge, ovulation, and the subsequent development of the corpus luteum. Usefulness in male infertility is also likely related to the increases in FSH and LH secretion.

The usual dose for the first course of Clomiphene is 50 mg (1 tablet) a day for 5 days in the early follicular phase of the cycle, following normal menstruation or a progestagen-induced withdrawal bleeding. Many regimes have been used, but most common begin either on day 2 or day 5. If this dose induces ovulation, there is no need to increase the dose in the following courses. If this dose induces ovulation, but pregnancy does  not occur, stimulation with Clomiphene Citrate is to be continued, but up to 6 stimulative courses. If the first course does not induce ovulation, the second course should be started with 100 mg a day (2 tablets of 50 mg taken in a single dose) for 5 days. If ovulation is not induced, 2 more stimulative courses of the same dose should be given. If the next three stimulative courses do not produce a successful result, the therapeutic trial is considered to be finished. If ovulation is induced, but pregnancy does not occur, maximum 6 courses with Clomiphene are recommended. However, if menstrual bleeding does not occur, the patient should be examined carefully for the possible pregnancy, and the next course of therapy should be delayed until the correct diagnosis has been determined.

Clomiphene Citrate is well tolerated. However a few side effects like dizziness, headache, nausea, vomiting, depression, fatigue, insomnia, vasomotor flushing, and allergic reaction may occur. Rarely ovarian enlargement and cyst formation may occur. All these effects disappear promptly after the treatment is discontinued.

Clomiphene citrate is contraindicated during pregnancy, in patients with liver diseases, ovarian cysts, bleeding of undetermined origin, patients with neoplasm of endometrium.

Clomiphene citrate should be used with caution in longer maintenance therapy, with alcoholic drinks & antidepressants.

No drug interaction has been reported during the administration of Clomiphene citrate.

This is not recommended in pregnancy. In some cases Clomiphene citrate may reduce lactation, if it is administered to a woman during lactating period. So it should be avoided during lactational period.

No such effects of acute over dosage of Clomiphene citrate have been reported. However, in case of over dosage, a few sign symptoms of nausea, vomiting, vasomotor flushes, scotoma, and ovarian enlargement with pelvic or abdominal pain may occur. In the event of over dosage appropriate supportive measures should be employed.

Clomiphene Citrate tablet should be stored below 25° C and protected from light & moisture.

Drugs for Infertility

Clomiphene has mainly antiestrogenic effects and some estrogenic effects. The mechanism in stimulating ovulation is unknown but is believed to be related to its antiestrogenic properties. By clomiphene competing with estrogen for binding sites at the hypothalamic level, the gonadotropins, follicle-stimulating hormone (FSH) and luteinizing hormone (LH), secretion is increased, which results in ovarian follicle maturation, followed by the preovulatory LH surge, ovulation, and the subsequent development of the corpus luteum. Usefulness in male infertility is also likely related to the increases in FSH and LH secretion.

The usual dose for the first course of Clomiphene is 50 mg (1 tablet) a day for 5 days in the early follicular phase of the cycle, following normal menstruation or a progestagen-induced withdrawal bleeding. Many regimes have been used, but most common begin either on day 2 or day 5. If this dose induces ovulation, there is no need to increase the dose in the following courses. If this dose induces ovulation, but pregnancy does  not occur, stimulation with Clomiphene Citrate is to be continued, but up to 6 stimulative courses. If the first course does not induce ovulation, the second course should be started with 100 mg a day (2 tablets of 50 mg taken in a single dose) for 5 days. If ovulation is not induced, 2 more stimulative courses of the same dose should be given. If the next three stimulative courses do not produce a successful result, the therapeutic trial is considered to be finished. If ovulation is induced, but pregnancy does not occur, maximum 6 courses with Clomiphene are recommended. However, if menstrual bleeding does not occur, the patient should be examined carefully for the possible pregnancy, and the next course of therapy should be delayed until the correct diagnosis has been determined.

Clomiphene Citrate is well tolerated. However a few side effects like dizziness, headache, nausea, vomiting, depression, fatigue, insomnia, vasomotor flushing, and allergic reaction may occur. Rarely ovarian enlargement and cyst formation may occur. All these effects disappear promptly after the treatment is discontinued.

Clomiphene citrate is contraindicated during pregnancy, in patients with liver diseases, ovarian cysts, bleeding of undetermined origin, patients with neoplasm of endometrium.

Clomiphene citrate should be used with caution in longer maintenance therapy, with alcoholic drinks & antidepressants.

No drug interaction has been reported during the administration of Clomiphene citrate.

This is not recommended in pregnancy. In some cases Clomiphene citrate may reduce lactation, if it is administered to a woman during lactating period. So it should be avoided during lactational period.

No such effects of acute over dosage of Clomiphene citrate have been reported. However, in case of over dosage, a few sign symptoms of nausea, vomiting, vasomotor flushes, scotoma, and ovarian enlargement with pelvic or abdominal pain may occur. In the event of over dosage appropriate supportive measures should be employed.

Clomiphene Citrate tablet should be stored below 25° C and protected from light & moisture.

Drugs for Infertility

Clomiphene has mainly antiestrogenic effects and some estrogenic effects. The mechanism in stimulating ovulation is unknown but is believed to be related to its antiestrogenic properties. By clomiphene competing with estrogen for binding sites at the hypothalamic level, the gonadotropins, follicle-stimulating hormone (FSH) and luteinizing hormone (LH), secretion is increased, which results in ovarian follicle maturation, followed by the preovulatory LH surge, ovulation, and the subsequent development of the corpus luteum. Usefulness in male infertility is also likely related to the increases in FSH and LH secretion.

The usual dose for the first course of Clomiphene is 50 mg (1 tablet) a day for 5 days in the early follicular phase of the cycle, following normal menstruation or a progestagen-induced withdrawal bleeding. Many regimes have been used, but most common begin either on day 2 or day 5. If this dose induces ovulation, there is no need to increase the dose in the following courses. If this dose induces ovulation, but pregnancy does  not occur, stimulation with Clomiphene Citrate is to be continued, but up to 6 stimulative courses. If the first course does not induce ovulation, the second course should be started with 100 mg a day (2 tablets of 50 mg taken in a single dose) for 5 days. If ovulation is not induced, 2 more stimulative courses of the same dose should be given. If the next three stimulative courses do not produce a successful result, the therapeutic trial is considered to be finished. If ovulation is induced, but pregnancy does not occur, maximum 6 courses with Clomiphene are recommended. However, if menstrual bleeding does not occur, the patient should be examined carefully for the possible pregnancy, and the next course of therapy should be delayed until the correct diagnosis has been determined.

Clomiphene Citrate is well tolerated. However a few side effects like dizziness, headache, nausea, vomiting, depression, fatigue, insomnia, vasomotor flushing, and allergic reaction may occur. Rarely ovarian enlargement and cyst formation may occur. All these effects disappear promptly after the treatment is discontinued.

Clomiphene citrate is contraindicated during pregnancy, in patients with liver diseases, ovarian cysts, bleeding of undetermined origin, patients with neoplasm of endometrium.

Clomiphene citrate should be used with caution in longer maintenance therapy, with alcoholic drinks & antidepressants.

No drug interaction has been reported during the administration of Clomiphene citrate.

This is not recommended in pregnancy. In some cases Clomiphene citrate may reduce lactation, if it is administered to a woman during lactating period. So it should be avoided during lactational period.

No such effects of acute over dosage of Clomiphene citrate have been reported. However, in case of over dosage, a few sign symptoms of nausea, vomiting, vasomotor flushes, scotoma, and ovarian enlargement with pelvic or abdominal pain may occur. In the event of over dosage appropriate supportive measures should be employed.

Clomiphene Citrate tablet should be stored below 25° C and protected from light & moisture.

Drugs for Infertility

Clomiphene has mainly antiestrogenic effects and some estrogenic effects. The mechanism in stimulating ovulation is unknown but is believed to be related to its antiestrogenic properties. By clomiphene competing with estrogen for binding sites at the hypothalamic level, the gonadotropins, follicle-stimulating hormone (FSH) and luteinizing hormone (LH), secretion is increased, which results in ovarian follicle maturation, followed by the preovulatory LH surge, ovulation, and the subsequent development of the corpus luteum. Usefulness in male infertility is also likely related to the increases in FSH and LH secretion.

The usual dose for the first course of Clomiphene is 50 mg (1 tablet) a day for 5 days in the early follicular phase of the cycle, following normal menstruation or a progestagen-induced withdrawal bleeding. Many regimes have been used, but most common begin either on day 2 or day 5. If this dose induces ovulation, there is no need to increase the dose in the following courses. If this dose induces ovulation, but pregnancy does  not occur, stimulation with Clomiphene Citrate is to be continued, but up to 6 stimulative courses. If the first course does not induce ovulation, the second course should be started with 100 mg a day (2 tablets of 50 mg taken in a single dose) for 5 days. If ovulation is not induced, 2 more stimulative courses of the same dose should be given. If the next three stimulative courses do not produce a successful result, the therapeutic trial is considered to be finished. If ovulation is induced, but pregnancy does not occur, maximum 6 courses with Clomiphene are recommended. However, if menstrual bleeding does not occur, the patient should be examined carefully for the possible pregnancy, and the next course of therapy should be delayed until the correct diagnosis has been determined.

Clomiphene Citrate is well tolerated. However a few side effects like dizziness, headache, nausea, vomiting, depression, fatigue, insomnia, vasomotor flushing, and allergic reaction may occur. Rarely ovarian enlargement and cyst formation may occur. All these effects disappear promptly after the treatment is discontinued.

Clomiphene citrate is contraindicated during pregnancy, in patients with liver diseases, ovarian cysts, bleeding of undetermined origin, patients with neoplasm of endometrium.

Clomiphene citrate should be used with caution in longer maintenance therapy, with alcoholic drinks & antidepressants.

No drug interaction has been reported during the administration of Clomiphene citrate.

This is not recommended in pregnancy. In some cases Clomiphene citrate may reduce lactation, if it is administered to a woman during lactating period. So it should be avoided during lactational period.

No such effects of acute over dosage of Clomiphene citrate have been reported. However, in case of over dosage, a few sign symptoms of nausea, vomiting, vasomotor flushes, scotoma, and ovarian enlargement with pelvic or abdominal pain may occur. In the event of over dosage appropriate supportive measures should be employed.

Clomiphene Citrate tablet should be stored below 25° C and protected from light & moisture.

Oral Anti-coagulants

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.

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.

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.

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.

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.

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.

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 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.

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

Eye Anti-Infectives & Antiseptics, Tetracycline group of drugs, Topical antibiotics for Acne

Oxytetracycline inhibits cell growth by inhibiting translation. It binds to the 30S ribosomal subunit and prevents the amino-acyl tRNA from binding to the A site of the ribosome. The binding is reversible in nature. Oxytetracycline is lipophilic and can easily pass through the cell membrane or passively diffuses through porin channels in the bacterial membrane.

Adults: 250-500 mg every 6 hours. Food, milk and some dairy products interfere with the absorption of Tetracyclines. So Tetracyclines should be given one hour before or two hours after meals.

Side effects of Oxytetracycline, which have been reported in some patients, are anorexia, nausea, vomiting, diarrhoea, glossitis, skin rashes and urticaria.

Oxytetracycline should not be used with patients who are hypersensitive to Tetracyclines. It should not be used in children under 12 years of age. It is contraindicated in pregnant women because of tooth staining in the fetus and possible growth retardation effects.

Oxytetracycline should be used with caution in renal impairment.

Antacids containing Aluminium, Calcium, Magnesium, Zinc or Iron salts may impair the absorption of Oxytetracycline. In long term therapy, Tetracyclines depress plasma prothrombin activity and reduced doses of concomitant anticoagulants may be necessary. A few cases of pregnancy or breakthrough bleeding have been attributed to the concurrent use of Tetracyclines or Oxytetracyclines with oral contraceptives.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues and can have toxic effects on the developing fetus. Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. Tetracyclines are present in the milk of lactating women who are taking a drug in this class.

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

Penicillinase-resistant penicillins

Flucloxacillin is active against Gram-positive organisms including penicillinase producing strains. It has little activity against Gram-negative bacilli. Flucloxacillin acts by inhibiting the formation of cell wall of bacteria. Flucloxacillin is isoxazolyl penicillin which combined the properties of resistance to hydrolysis by penicillinase, gastric acid stability and activity against gram-positive bacteria. Flucloxacillin is a bactericidal antibiotic that is particularly useful against penicillinase-producing staphylococci. Flucloxacillin kills bacterial cellwall, thus interfering with peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure that provides the cell wall with its mechanical stability. The final stage of peptidoglycan synthesis involves the completion of the cross-linking with the terminal glycine residue of the pentaglycin bridge linking to the fourth residue of the pentapeptide (D-alanine). The transpeptidase enzyme that performs this step is inhibited by Flucloxacillin. As a result the bacterial cellwall is weakened, the cell swells and then ruptures. Flucloxacillin resists the action of bacterial penicillinase probably because of the steric hindrance induced by the acyl side chain which prevents the opening of the β- lactam ring.

Oral administration:

• Adult: 250 mg four times daily. Dosage may be doubled in severe infections. In osteomyelitis and endocarditis, up to 8 gm daily is used in 6-8 hourly divided doses.
• Children (2-10 years): 1/2 of adult dose.
• Children (Under 2 years): 1/4 of adult dose.

Parenteral administration:
Adult or Elderly:

• Intramuscular Injection: 250 mg four times daily.
• Intravenous Injection: 250 mg-1 g four times daily by slow injection over 3 to 4 minutes or by intravenous infusion.
• All systemic doses may be doubled in severe infections: doses up to 8 g daily have been suggested for endocarditis or osteomyelitis.

Children:

• 2-10 years: half of the adult dose.
• Under 2 years: a quarter of the adult dose.

Oral doses should be administered 1 hour before meal.

There have been some common side effects of gastrointestinal tract such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported.

Flucloxacillin is contraindicated in penicillin hypersensitive patients.

Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction. Caution should also be exercised in the treatment of patients with an allergic diathesis.

Concurrent use of Flucloxacillin and may result in increased level of Flucloxacillin in blood for prolonged period.

US FDA Pregnancy Category of Flucloxacillin is B. There are, 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. Flucloxacillin have been shown to be excreted in human milk. So, caution should be exercised when Flucloxacillin is administered to a lactating mother.

In severe renal failure (creatinine clearance <10 ml/min), a reduction in dose or an extension of dose interval should be considered.

Flucloxacillin has been used in other routes in conjunction with systemic therapy. It has been administered in a dose of 250 mg to 500 mg daily by intraarticular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intrapleural injection in a dose of 250 mg daily. Using powder for injection, 125 mg-250 mg has been dissolved in 3 ml of sterile water and inhaled by nebuliser four times daily.

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

Carbetocin is indicated for the prevention of uterine atony and postpartum haemorrhage (excessive bleeding) following delivery of the infant by elective caesarean section under epidural or spinal anaesthesia.

Drugs acting on the Uterus

Carbetocin is a drug used to control postpartum hemorrhage, bleeding after giving birth. It is an analogue of oxytocin, and its action is similar to that of oxytocin; it causes contraction of the uterus. Carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions, and increased uterine tone. The oxytocin receptor content of the uterus is very low in the non-pregnant state, and increases during pregnancy, reaching a peak at the time of delivery.

A single intravenous dose of 100 mcg of carbetocin injection is administered by bolus injection, slowly over 1 minute, only when infant delivery has been completed by caesarean section under epidural or spinal anaesthesia. carbetocin is to be used as a single dose only.

10-40% of patients experienced nausea, vomiting, abdominal pain, itching skin, increased body temperature, trembling and weakness. Infrequent adverse events (1-5% of patients) included back pain, dizziness, metallic taste, anaemia, sweating, chest pain, dyspnoea, chills, tachycardia and anxiety.

Because of its long duration of action relative to oxytocin, uterine contractions produced by carbetocin cannot be stopped by simply discontinuing the medication. Therefore, carbetocin should not be administered prior to delivery of the infant for any reason, including elective or medical induction of labour. Inappropriate use of carbetocin during pregnancy could theoretically mimic the symptoms of oxytocin overdosage, including hyperstimulation of the uterus with strong (hypertonic) or prolonged (tetanic) contractions, tumultuous labour, uterine rupture, cervical and vaginal lacerations, postpartum haemorrhage, utero-placental hypoperfusion and variable deceleration of foetal heart, foetal hypoxia, hypercapnia, or death. Carbetocin should not be used in patients with a history of hypersensitivity to oxytocin or carbetocin. Carbetocin should not be used in patients with cardio vascular disease, especially coronary artery disease, valvular heart disease, cardiomyopathy and heart failure. Carbetocin is not intended for use in children. 

No specific drug interactions have been reported with carbetocin.

Use of carbetocin injection is contraindicated during pregnancy. Small amounts of carbetocin has been shown to cross over from plasma into the breast milk of nursing women. The small amount of carbetocin ingested by infant would not be expected to present a significant safety concern.

Overdosage of carbetocin can be expected to produce enhanced pharmacological effects associated with uterine hyperactivity and pain. Treatment consists of symptomatic and supportive management.

Store at 2-8°C. Do not freeze. Keep away from light. Once the ampoule has been opened, the product should be used immediately.

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.

Cytotoxic Chemotherapy

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.

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.

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.

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

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.

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.

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).

Renal Impairment: Dose adjustment may be needed

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

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.

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.

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.

Cytotoxic Chemotherapy

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.

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.

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.

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

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.

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.

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).

Renal Impairment: Dose adjustment may be needed

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

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.

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.

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.

Cytotoxic Chemotherapy

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.

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.

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.

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

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.

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.

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).

Renal Impairment: Dose adjustment may be needed

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

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.

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.

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.

Cytotoxic Chemotherapy

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.

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.

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.

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

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.

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.

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).

Renal Impairment: Dose adjustment may be needed

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

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.

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.

Escitalopram Oxalate is indicated in the-

• Treatment of major depressive episodes.
• Treatment of panic disorder with or without agoraphobia.
• Treatment of social anxiety disorder (social phobia).
• Treatment of generalised anxiety disorder.
• Treatment of obsessive-compulsive disorder.

SSRIs & related anti-depressant drugs

Escitalopram is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer of the racemic bicyclic phthalate derivative citalopram. Escitalopram is at least 100 fold more potent than the R-enantiomer with respect to inhibition of 5-HT reuptake. Escitalopram has no or very low affinity for serotonergic or other receptors including alpha- and beta-adrenergic Dopamine, Histamine, Muscarinic and benzodiazepine receptors.

Safety of daily doses above 20 mg has not been demonstrated. Escitalopram Oxalate is administered as a single daily dose and may be taken with or without food.

Major depressive episodes: Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually, 2-4 weeks are necessary to obtain an antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response.

Panic disorder with or without agoraphobia: An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment lasts several months.

Social anxiety disorder: Usual dosage is 10 mg once daily. Usually, 2-4 weeks are necessary to obtain symptom relief. The dose may subsequently, depending on individual patient response, be decreased to 5 mg or increased to a maximum of 20 mg daily. Social anxiety disorder is a disease with a chronic course, and treatment for 12 weeks is recommended to consolidate response. Long-term treatment of responders has been studied for 6 months and can be considered on an individual basis to prevent relapse; treatment benefits should be re-evaluated at regular intervals. Social anxiety disorder is a well-defined diagnostic terminology of a specific disorder, which should not be confounded with excessive shyness. Pharmacotherapy is only indicated if the disorder interferes significantly with professional and social activities. The place of this treatment compared to cognitive behavioural therapy has not been assessed. Pharmacotherapy is part of an overall therapeutic strategy.

Generalised anxiety disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. Long term treatment of responders has been studied for at least 6 months in patients receiving 20 mg/day. Treatment benefits and dose should be re-evaluated at regular intervals.

Obsessive-Compulsive Disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom-free. Treatment benefits and dose should be re-evaluated at regular intervals.

Escitalopram should generally be administered once daily, morning or evening with or without food.

SSRIs are less sedating and have fewer antimuscarinic and cardiotoxic effects than tricyclic antidepressants. Side-effects of the SSRIs include gastrointestinal effects (dose-related and fairly common include nausea, vomiting, dyspepsia, abdominal pain, diarrhoea, constipation), anorexia with weight loss (increased appetite and weight gain also reported) and hypersensitivity reactions including rash, urticaria, angioedema, anaphylaxis, arthralgia, myalgia, and photosensitivity; other side-effects include dry mouth, nervousness, anxiety, headache, insomnia, tremor, dizziness, asthenia, hallucinations, drowsiness, convulsions, galactorrhoea, sexual dysfunction, urinary retention, sweating, hypomania or mania, movement disorders and dyskinesias, visual disturbances.

Escitalopram is contraindicated in patients with known hypersensitivity to Escitalopram or Citalopram or any of the inactive ingredients of the drug product. Concomitant use of escitalopram in patients taking monoamine oxidase/pimozide is contraindicated.

SSRIs should be used with caution in patients with epilepsy (avoid if poorly controlled, discontinue if convulsions develop), concurrent electroconvulsive therapy (prolonged seizures reported with fluoxetine), history of mania, cardiac disease, diabetes mellitus, angle-closure glaucoma, concomitant use of drugs that increase risk of bleeding, history of bleeding disorders (especially gastro-lntestinal bleeding), hepatic and renal impairment.

As SSRI or related antidepressants should not be started until 2 weeks after stopping an MAOI. Conversely, an MAOI should not. be started until at least a week after an SSRI or related antidepressant has been stopped (2 weeks in the case of paroxetine and sertraline, at least 5 weeks in the case of fluoxetine).

When treating a pregnant woman with Escitalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. It is excreted in human breast milk. The decision whether to continue or discontinue either nursing or Escitalopram therapy should take into account the risk of citalopram exposure for the infant and the benefits Escitalopram treatment for the mother.

Elderly patients (>65 years of age): Initial dosage is 5 mg once daily. Depending on the individual patient response the dose may be increased to 10 mg daily. The efficacy of escitalopram in social anxiety disorder has not been studied in elderly patients.

Children and adolescents (<18 years): Escitalopram Oxalate should not be used in the treatment of children and adolescents under the age of 18 years.

Reduced renal function: Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CLCR less than 30 ml/min).

Reduced hepatic function: An initial dose of 5 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. Depending on individual patient response, the dose may be increased to 10 mg daily. Caution and extra careful dose titration is advised in patients with severely reduced hepatic function.

Poor metabolizers of CYP2C19: For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily. Discontinuation symptoms seen when stopping treatment. Abrupt discontinuation should be avoided.

When stopping treatment with escitalopram the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of discontinuation symptoms. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.

Symptoms: Symptoms seen in a reported overdose of escitalopram include symptoms mainly related to the central nervous system (ranging from dizziness, tremor, and agitation to rare cases of serotonin syndrome, convulsion, and coma), the gastrointestinal system (nausea/vomiting), and the cardiovascular system (hypotension, tachycardia, QT interval, prolongation, and arrhythmia) and electrolyte/fluid balance conditions (hypokalaemia, hyponatremia).

Management: There is no specific antidote. Establish and maintain an airway, ensure adequate oxygenation and respiratory function. Gastric lavage and the use of activated charcoal should be considered. Gastric lavage should be carried out as soon as possible after oral ingestion. Cardiac and vital signs monitoring are recommended along with general symptomatic supportive measures. ECG monitoring is advised in case of overdose, in patients with congestive heart failure/bradyarrhythmias, in patients using concomitant medications that prolong the QT-interval, or in patients with altered metabolism, e.g. liver impairment.

Store below 30°C temperature and protect from light & moisture. Keep the medicine out of the reach of children.

Escitalopram Oxalate is indicated in the-

• Treatment of major depressive episodes.
• Treatment of panic disorder with or without agoraphobia.
• Treatment of social anxiety disorder (social phobia).
• Treatment of generalised anxiety disorder.
• Treatment of obsessive-compulsive disorder.

SSRIs & related anti-depressant drugs

Escitalopram is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer of the racemic bicyclic phthalate derivative citalopram. Escitalopram is at least 100 fold more potent than the R-enantiomer with respect to inhibition of 5-HT reuptake. Escitalopram has no or very low affinity for serotonergic or other receptors including alpha- and beta-adrenergic Dopamine, Histamine, Muscarinic and benzodiazepine receptors.

Safety of daily doses above 20 mg has not been demonstrated. Escitalopram Oxalate is administered as a single daily dose and may be taken with or without food.

Major depressive episodes: Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually, 2-4 weeks are necessary to obtain an antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response.

Panic disorder with or without agoraphobia: An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment lasts several months.

Social anxiety disorder: Usual dosage is 10 mg once daily. Usually, 2-4 weeks are necessary to obtain symptom relief. The dose may subsequently, depending on individual patient response, be decreased to 5 mg or increased to a maximum of 20 mg daily. Social anxiety disorder is a disease with a chronic course, and treatment for 12 weeks is recommended to consolidate response. Long-term treatment of responders has been studied for 6 months and can be considered on an individual basis to prevent relapse; treatment benefits should be re-evaluated at regular intervals. Social anxiety disorder is a well-defined diagnostic terminology of a specific disorder, which should not be confounded with excessive shyness. Pharmacotherapy is only indicated if the disorder interferes significantly with professional and social activities. The place of this treatment compared to cognitive behavioural therapy has not been assessed. Pharmacotherapy is part of an overall therapeutic strategy.

Generalised anxiety disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. Long term treatment of responders has been studied for at least 6 months in patients receiving 20 mg/day. Treatment benefits and dose should be re-evaluated at regular intervals.

Obsessive-Compulsive Disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom-free. Treatment benefits and dose should be re-evaluated at regular intervals.

Escitalopram should generally be administered once daily, morning or evening with or without food.

SSRIs are less sedating and have fewer antimuscarinic and cardiotoxic effects than tricyclic antidepressants. Side-effects of the SSRIs include gastrointestinal effects (dose-related and fairly common include nausea, vomiting, dyspepsia, abdominal pain, diarrhoea, constipation), anorexia with weight loss (increased appetite and weight gain also reported) and hypersensitivity reactions including rash, urticaria, angioedema, anaphylaxis, arthralgia, myalgia, and photosensitivity; other side-effects include dry mouth, nervousness, anxiety, headache, insomnia, tremor, dizziness, asthenia, hallucinations, drowsiness, convulsions, galactorrhoea, sexual dysfunction, urinary retention, sweating, hypomania or mania, movement disorders and dyskinesias, visual disturbances.

Escitalopram is contraindicated in patients with known hypersensitivity to Escitalopram or Citalopram or any of the inactive ingredients of the drug product. Concomitant use of escitalopram in patients taking monoamine oxidase/pimozide is contraindicated.

SSRIs should be used with caution in patients with epilepsy (avoid if poorly controlled, discontinue if convulsions develop), concurrent electroconvulsive therapy (prolonged seizures reported with fluoxetine), history of mania, cardiac disease, diabetes mellitus, angle-closure glaucoma, concomitant use of drugs that increase risk of bleeding, history of bleeding disorders (especially gastro-lntestinal bleeding), hepatic and renal impairment.

As SSRI or related antidepressants should not be started until 2 weeks after stopping an MAOI. Conversely, an MAOI should not. be started until at least a week after an SSRI or related antidepressant has been stopped (2 weeks in the case of paroxetine and sertraline, at least 5 weeks in the case of fluoxetine).

When treating a pregnant woman with Escitalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. It is excreted in human breast milk. The decision whether to continue or discontinue either nursing or Escitalopram therapy should take into account the risk of citalopram exposure for the infant and the benefits Escitalopram treatment for the mother.

Elderly patients (>65 years of age): Initial dosage is 5 mg once daily. Depending on the individual patient response the dose may be increased to 10 mg daily. The efficacy of escitalopram in social anxiety disorder has not been studied in elderly patients.

Children and adolescents (<18 years): Escitalopram Oxalate should not be used in the treatment of children and adolescents under the age of 18 years.

Reduced renal function: Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CLCR less than 30 ml/min).

Reduced hepatic function: An initial dose of 5 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. Depending on individual patient response, the dose may be increased to 10 mg daily. Caution and extra careful dose titration is advised in patients with severely reduced hepatic function.

Poor metabolizers of CYP2C19: For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily. Discontinuation symptoms seen when stopping treatment. Abrupt discontinuation should be avoided.

When stopping treatment with escitalopram the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of discontinuation symptoms. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.

Symptoms: Symptoms seen in a reported overdose of escitalopram include symptoms mainly related to the central nervous system (ranging from dizziness, tremor, and agitation to rare cases of serotonin syndrome, convulsion, and coma), the gastrointestinal system (nausea/vomiting), and the cardiovascular system (hypotension, tachycardia, QT interval, prolongation, and arrhythmia) and electrolyte/fluid balance conditions (hypokalaemia, hyponatremia).

Management: There is no specific antidote. Establish and maintain an airway, ensure adequate oxygenation and respiratory function. Gastric lavage and the use of activated charcoal should be considered. Gastric lavage should be carried out as soon as possible after oral ingestion. Cardiac and vital signs monitoring are recommended along with general symptomatic supportive measures. ECG monitoring is advised in case of overdose, in patients with congestive heart failure/bradyarrhythmias, in patients using concomitant medications that prolong the QT-interval, or in patients with altered metabolism, e.g. liver impairment.

Store below 30°C temperature and protect from light & moisture. Keep the medicine out of the reach of children.

Paroxetine  is indicated in:

• Major Depressive Disorder
• Obsessive Compulsive Disorder
• Panic Disorder
• Social Anxiety Disorder
• Generalized Anxiety Disorder
• Posttraumatic Stress Disorder.

SSRIs & related anti-depressant drugs

The efficacy of Paroxetine is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-hydroxy-tryptamine, 5 HT). Studies at clinically relevant doses in humans have demonstrated that paroxetine blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that paroxetine is a potent and highly selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. In vitro radioligand binding studies indicate that paroxetine has little affinity for muscarinic, alpha1, alpha2, beta adrenergic, dopamine (D2), 5-HT1, 5 HT2 and histamine (H1)-receptors; antagonism of muscarinic, histaminergic and alpha1-adrenergic receptors has been associated with various anticholinergic, sedative and cardiovascular effects for other psychotropic drugs. Because the relative potencies of paroxetine’s major metabolites are at most 1/50 of the parent compound, they are essentially inactive.

Major Depressive Disorder:

• Usual Initial Dosage: Paroxetine (Paroxetine hydrochloride) should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day. Some patients not responding to a 20 mg dose may benefit from dose increases, in 10 mg/day increments, up to a maximum of 50 mg/day. Dose changes should occur at intervals of at least 1 week.
• Maintenance Therapy: Systematic evaluation of the efficacy of Paroxetine hydrochloride has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg.

Obsessive Compulsive Disorder (OCD):

• Usual Initial Dosage: Paroxetine (Paroxetine hydrochloride) should be administered as a single daily dose with or without food, usually in the morning. The recommended dose of Paroxetine in the treatment of OCD is 40 mg daily. Patients should be started on 20 mg/day and the dose can be increased in 10 mg/day increments. Dose changes should occur at intervals of at least 1 week.
• Maintenance Therapy: Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Panic Disorder:

• Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The target dose of Paroxetine in the treatment of panic disorder is 40 mg/day. Patients should be started on 10 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week. The maximum dosage should not exceed 60 mg/day.
• Maintenance Therapy: Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Social Anxiety Disorder (SAD):

• Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dosage is 20 mg/day.
• Maintenance Therapy: Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Generalized Anxiety Disorder (GAD):

• Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended starting dosage and the established effective dosage is 20 mg/day.
• Maintenance Therapy: Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Posttraumatic Stress Disorder (PTSD):

• Usual Initial Dosage: Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended starting dosage and the established effective dosage is 20 mg/day. Dose changes, if indicated, should occur in 10 mg/day increments and at intervals of at least 1 week.
• Maintenance Therapy: Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Major depressive disorder: Asthenia, sweating, nausea, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, ejaculatory disturbance and other male genital disorders.

Obsessive compulsive disorder: Nausea, dry mouth, decreased appetite, constipation, dizziness, somnolence, tremor, sweating, impotence and abnormal ejaculation.

Panic disorder: Asthenia, sweating, decreased appetite, decreased libido , tremor, abnormal ejaculation, female genital disorders and impotence.

Social anxiety disorder: Sweating, nausea, dry mouth, constipation, decreased appetite, somnolence, tremor, decreased libido, yawn, abnormal ejaculation, female genital disorders and impotence.

Generalised anxiety disorder: Asthenia, infection, constipation, decreased appetite, dry mouth, nausea, decreased libido, somnolence, tremor, sweating and abnormal
ejaculation.

Post-traumatic stress disorder: Asthenia, sweating nausea, dry mouth, diarrhoea, decreased appetite, somnolence, decreased libido, abnormal ejaculation, female genital disorders and impotence.

Concomitant use in patients taking either monoamine oxidase inhibitors (MAOIs) or thioridazine is contraindicated. This is contraindicated in patients with a hypersensitivity to Paroxetine.

Cardiac conditions: Paroxetine does not produce clinically significant changes in blood pressure, heart rate and ECG. Nevertheless, as with all psychoactive drugs, caution is advised when treating patients with cardiac conditions.

Epilepsy: As with other antidepressants, Paroxetine should be used with caution in-patients with epilepsy.

Seizures: Overall, the incidence of seizures is < 0.1% in patients treated with Paroxetine. Paroxetine should be discontinued in any patient who develops seizures.

ECT: There is little clinical experience of concurrent administration of Paroxetine with ECT.

Ability to drive/use machines: Clinical experience has shown that therapy with Paroxetine is not associated with impairment of cognitive or psychomotor function. However, as with all psychoactive drugs, patients should be cautioned about their ability to drive a car and operate machinery.

Discontinuation of Treatment with Paroxetine: Recent clinical trials supporting the various approved indications of Paroxetine employed a taper phase regimen, rather than an abrupt discontinuation of treatment. The taper phase regimen used in GAD and PTSD clinical trials involved an incremental decrease in the daily dose by 10 mg/day at weekly intervals. When a daily dose of 20 mg/day was reached, patients were continued on this dose for 1 week before treatment was stopped.

Food/antacids: The absorption and pharmacokinetics of Paroxetine are not affected by food or antacids.

Tryptophan: As with other 5-HT re uptake inhibitors, animal studies indicate that an interaction between Paroxetine and Tryptophan may occur, resulting in a ‘serotonin syndrome’ suggested by a combination of agitation, restlessness and gastrointestinal symptoms including diarrhoea. 

Drug metabolizing enzyme inducers /inhibitors: The metabolism and pharmacokinetics of Paroxetine may be affected by drugs, which induce or inhibit hepatic drug metabolizing enzymes. When Paroxetine is to be coadministered with a known drug metabolizing inhibitor, consideration should be given to using doses at the lower end of the range. No initial dosage adjustment of Paroxetine is considered necessary when it is to be co-administered with known drug metabolizing enzyme inducers. Any subsequent dosage adjustment should be guided by clinical effect (tolerabilityand efficacy).

Alcohol: Although Paroxetine does not increase the impairment of mental and motor skill caused by alcohol, the concomitant use of Paroxetine and alcohol in depressed patients is not advised.

Haloperidol/amylobarbitone/oxazepam: Experience in a limited number of healthy subjects has shown that Paroxetine did not increase the sedation and drowsiness associated with haloperidol, amylobarbitone or oxazepam when given in combination.

MAOls: As with other 5-HT re uptake inhibitors, animal studies indicate that an interaction between Paroxetine and monoamine oxidase (MAO) inhibitors may occur.

Lithium: Since there is little clinical experience, and there have been reports of interaction of lithium with other 5-HT re-uptake inhibitors, the concurrent administration of Paroxetine and lithium should be undertaken with caution.

Lithium levels should be monitored. Phenytoin / anticonvulsants: Co-administration of Paroxetine and phenytoin is associated with decreased plasma concentrations of Paroxetine and increased adverse experiences. Co-administration of Paroxetine with other anticonvulsants may also be associated with an increased incidence of adverse experiences.

Warfarin: Preliminary data suggest that there may be a pharmacodynamic interaction between Paroxetine and warfarin, which may result in increased bleeding in the presence of unaltered prothrombin times. Paroxetine should therefore be administered with great caution to patients receiving oral anticoagulants.

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery: The effect of Paroxetine on labor and delivery in humans is unknown.

Nursing Mothers: Like many other drugs, Paroxetine is secreted in human milk, and caution should be exercised when Paroxetine hydrochloride is administered to a nursing woman.

Dosage for Elderly or Debilitated, and Patients with Severe Renal or Hepatic Impairment: The recommended initial dose is 10 mg/day for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 40 mg/day.

Keep out of the reach of children. Store at a cool and dry place. Protect from light and moisture.

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.

Cytotoxic Chemotherapy

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.

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.

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.

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

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.

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.

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).

Renal Impairment: Dose adjustment may be needed

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

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.

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.

Oxcarbazepine is indicated for:

Adults: Monotherapy or adjunctive therapy in the treatment of partial seizures

Pediatrics:

• Monotherapy in the treatment of partial seizures in children 4-16 years
• Adjunctive therapy in the treatment of partial seizures in children 2–16 years

Adjunct anti-epileptic drugs

The pharmacological activity of Oxcarbazepine is primarily exerted through the metabolite derivative (the monohydroxy derivative, MHD) of Oxcarbazepine. The mechanism of action of Oxcarbazepine and MHD is thought to be mainly based on blockade of voltage-sensitive sodium channels, thus resulting in stabilization of hyper excited neural membranes, inhibition of repetitive neuronal firing and diminishment of propagation of synaptic impulses.

Adults: initiate with a dose of 600 mg/day, given twice-a-day

• Adjunctive Therapy: Maximum increment of 600 mg/day at approximately weekly intervals. The recommended daily dose is 1200 mg/day
• Conversion to Monotherapy: withdrawal concomitant over 3 to 6 weeks;reach maximum dose of Oxcarbazepine in 2 to 4 weeks with increments of 600 mg/day at weekly intervals to a recommended daily dose of 2400 mg/day
• Initiation of Monotherapy: Increments of 300 mg/day every third day to a dose of 1200 mg/day.
• Creatinine Clearance <30 mL/min: Initiate at one half the usual starting dose and increase slowly

Pediatrics: initiation with 8 to 10 mg/kg/day, given twice-a-day. For patients aged 2 to <4 years and under 20 kg, a starting dose of 16 to 20 mg/kg/day may be considered. Recommended daily dose is dependent upon patient weight.

• Adjunctive Patients (Aged 2–16 Years): For patients aged 4 to 16 years, target maintenance dose should be achieved over 2 weeks. For patients aged 2 to <4 years, maximum maintenance dose should be achieved over 2 to 4 weeks and should not to exceed 60 mg/kg/day
• Conversion to Monotherapy for Patients (Aged 4-16 Years): Maximum increment of 10 mg/kg/day at weekly intervals, concomitant antiepileptic drugs can be completely withdrawn over 3 to 6 weeks
• Initiation of Monotherapy for Patients (Aged 4–16 Years): Increments of 5 mg/kg/day every third day

The most commonly reported adverse reactions are somnolence, headache, dizziness, diplopia, nausea; vomiting and fatigue. Very rarely clinically significant hyponatraemia can develop during Oxazep use. Class I (immediate) hypersensitivity reactions including rash, pruritus, urticaria, angioedema and reports of anaphylaxis have been received.

It is contraindicated to patients with hypersensitivity to the active substance or to any of the excipients.

Alcohol: Caution should be exercised if alcohol is taken in combination with Oxazep therapy, due to a possible additive sedative effect.

Withdrawal: As with all antiepileptic medicinal products, Oxazep should be withdrawn gradually to minimise the potential of increased seizure frequency.

Oxcarbazepine and its metabolite inhibit the enzyme CYP2C19 and therefore, interactions could arise when co-administering high doses of Oxazep with medicinal products that are metabolised by CYP2C19 (e.g. phenobarbital, phenytoin). Concurrent use of Oxazep with hormonal contraceptives may render few contraceptives ineffective (e.g. Ethinylestradiol and Levonorgestrel preparations). Co-administration of Oxazep lowers AUC of felodipine and Verapamil decreases bioavailability of MHD.

Pregnancy: Data on a limited number of pregnancies indicate that Oxcarbazepine may cause serious birth defects (e.g. cleft palate) when administered during pregnancy. In the newborn child. Bleeding disorders in the newborn caused by antiepileptic agents have been reported. As a precaution, vitamin K1 should be administered as a preventive measure in the last few weeks of pregnancy and to the newborn. Oxcarbazepine and its active metabolite (MHD) cross the placenta. Neonatal and maternal plasma MHD concentrations were similar in one case.

Lactation: Oxcarbazepine and its active metabolite (MHD) are excreted in human breast milk. Therefore, Oxazep should not be used during breast-feeding.

Oxcarbazepine is indicated for:

Adults: Monotherapy or adjunctive therapy in the treatment of partial seizures

Pediatrics:

• Monotherapy in the treatment of partial seizures in children 4-16 years
• Adjunctive therapy in the treatment of partial seizures in children 2–16 years

Adjunct anti-epileptic drugs

The pharmacological activity of Oxcarbazepine is primarily exerted through the metabolite derivative (the monohydroxy derivative, MHD) of Oxcarbazepine. The mechanism of action of Oxcarbazepine and MHD is thought to be mainly based on blockade of voltage-sensitive sodium channels, thus resulting in stabilization of hyper excited neural membranes, inhibition of repetitive neuronal firing and diminishment of propagation of synaptic impulses.

Adults: initiate with a dose of 600 mg/day, given twice-a-day

• Adjunctive Therapy: Maximum increment of 600 mg/day at approximately weekly intervals. The recommended daily dose is 1200 mg/day
• Conversion to Monotherapy: withdrawal concomitant over 3 to 6 weeks;reach maximum dose of Oxcarbazepine in 2 to 4 weeks with increments of 600 mg/day at weekly intervals to a recommended daily dose of 2400 mg/day
• Initiation of Monotherapy: Increments of 300 mg/day every third day to a dose of 1200 mg/day.
• Creatinine Clearance <30 mL/min: Initiate at one half the usual starting dose and increase slowly

Pediatrics: initiation with 8 to 10 mg/kg/day, given twice-a-day. For patients aged 2 to <4 years and under 20 kg, a starting dose of 16 to 20 mg/kg/day may be considered. Recommended daily dose is dependent upon patient weight.

• Adjunctive Patients (Aged 2–16 Years): For patients aged 4 to 16 years, target maintenance dose should be achieved over 2 weeks. For patients aged 2 to <4 years, maximum maintenance dose should be achieved over 2 to 4 weeks and should not to exceed 60 mg/kg/day
• Conversion to Monotherapy for Patients (Aged 4-16 Years): Maximum increment of 10 mg/kg/day at weekly intervals, concomitant antiepileptic drugs can be completely withdrawn over 3 to 6 weeks
• Initiation of Monotherapy for Patients (Aged 4–16 Years): Increments of 5 mg/kg/day every third day

The most commonly reported adverse reactions are somnolence, headache, dizziness, diplopia, nausea; vomiting and fatigue. Very rarely clinically significant hyponatraemia can develop during Oxazep use. Class I (immediate) hypersensitivity reactions including rash, pruritus, urticaria, angioedema and reports of anaphylaxis have been received.

It is contraindicated to patients with hypersensitivity to the active substance or to any of the excipients.

Alcohol: Caution should be exercised if alcohol is taken in combination with Oxazep therapy, due to a possible additive sedative effect.

Withdrawal: As with all antiepileptic medicinal products, Oxazep should be withdrawn gradually to minimise the potential of increased seizure frequency.

Oxcarbazepine and its metabolite inhibit the enzyme CYP2C19 and therefore, interactions could arise when co-administering high doses of Oxazep with medicinal products that are metabolised by CYP2C19 (e.g. phenobarbital, phenytoin). Concurrent use of Oxazep with hormonal contraceptives may render few contraceptives ineffective (e.g. Ethinylestradiol and Levonorgestrel preparations). Co-administration of Oxazep lowers AUC of felodipine and Verapamil decreases bioavailability of MHD.

Pregnancy: Data on a limited number of pregnancies indicate that Oxcarbazepine may cause serious birth defects (e.g. cleft palate) when administered during pregnancy. In the newborn child. Bleeding disorders in the newborn caused by antiepileptic agents have been reported. As a precaution, vitamin K1 should be administered as a preventive measure in the last few weeks of pregnancy and to the newborn. Oxcarbazepine and its active metabolite (MHD) cross the placenta. Neonatal and maternal plasma MHD concentrations were similar in one case.

Lactation: Oxcarbazepine and its active metabolite (MHD) are excreted in human breast milk. Therefore, Oxazep should not be used during breast-feeding.

Oxcarbazepine is indicated for:

Adults: Monotherapy or adjunctive therapy in the treatment of partial seizures

Pediatrics:

• Monotherapy in the treatment of partial seizures in children 4-16 years
• Adjunctive therapy in the treatment of partial seizures in children 2–16 years

Adjunct anti-epileptic drugs

The pharmacological activity of Oxcarbazepine is primarily exerted through the metabolite derivative (the monohydroxy derivative, MHD) of Oxcarbazepine. The mechanism of action of Oxcarbazepine and MHD is thought to be mainly based on blockade of voltage-sensitive sodium channels, thus resulting in stabilization of hyper excited neural membranes, inhibition of repetitive neuronal firing and diminishment of propagation of synaptic impulses.

Adults: initiate with a dose of 600 mg/day, given twice-a-day

• Adjunctive Therapy: Maximum increment of 600 mg/day at approximately weekly intervals. The recommended daily dose is 1200 mg/day
• Conversion to Monotherapy: withdrawal concomitant over 3 to 6 weeks;reach maximum dose of Oxcarbazepine in 2 to 4 weeks with increments of 600 mg/day at weekly intervals to a recommended daily dose of 2400 mg/day
• Initiation of Monotherapy: Increments of 300 mg/day every third day to a dose of 1200 mg/day.
• Creatinine Clearance <30 mL/min: Initiate at one half the usual starting dose and increase slowly

Pediatrics: initiation with 8 to 10 mg/kg/day, given twice-a-day. For patients aged 2 to <4 years and under 20 kg, a starting dose of 16 to 20 mg/kg/day may be considered. Recommended daily dose is dependent upon patient weight.

• Adjunctive Patients (Aged 2–16 Years): For patients aged 4 to 16 years, target maintenance dose should be achieved over 2 weeks. For patients aged 2 to <4 years, maximum maintenance dose should be achieved over 2 to 4 weeks and should not to exceed 60 mg/kg/day
• Conversion to Monotherapy for Patients (Aged 4-16 Years): Maximum increment of 10 mg/kg/day at weekly intervals, concomitant antiepileptic drugs can be completely withdrawn over 3 to 6 weeks
• Initiation of Monotherapy for Patients (Aged 4–16 Years): Increments of 5 mg/kg/day every third day

The most commonly reported adverse reactions are somnolence, headache, dizziness, diplopia, nausea; vomiting and fatigue. Very rarely clinically significant hyponatraemia can develop during Oxazep use. Class I (immediate) hypersensitivity reactions including rash, pruritus, urticaria, angioedema and reports of anaphylaxis have been received.

It is contraindicated to patients with hypersensitivity to the active substance or to any of the excipients.

Alcohol: Caution should be exercised if alcohol is taken in combination with Oxazep therapy, due to a possible additive sedative effect.

Withdrawal: As with all antiepileptic medicinal products, Oxazep should be withdrawn gradually to minimise the potential of increased seizure frequency.

Oxcarbazepine and its metabolite inhibit the enzyme CYP2C19 and therefore, interactions could arise when co-administering high doses of Oxazep with medicinal products that are metabolised by CYP2C19 (e.g. phenobarbital, phenytoin). Concurrent use of Oxazep with hormonal contraceptives may render few contraceptives ineffective (e.g. Ethinylestradiol and Levonorgestrel preparations). Co-administration of Oxazep lowers AUC of felodipine and Verapamil decreases bioavailability of MHD.

Pregnancy: Data on a limited number of pregnancies indicate that Oxcarbazepine may cause serious birth defects (e.g. cleft palate) when administered during pregnancy. In the newborn child. Bleeding disorders in the newborn caused by antiepileptic agents have been reported. As a precaution, vitamin K1 should be administered as a preventive measure in the last few weeks of pregnancy and to the newborn. Oxcarbazepine and its active metabolite (MHD) cross the placenta. Neonatal and maternal plasma MHD concentrations were similar in one case.

Lactation: Oxcarbazepine and its active metabolite (MHD) are excreted in human breast milk. Therefore, Oxazep should not be used during breast-feeding.

Aluminium Hydroxide and Magnesium Hydroxide is indicated for Hyperacidity, peptic ulcer, gastritis, heartburn, sour stomach & dyspepsia.

Antacids

This drug is well-balanced combination of essential non-systemic antacids which excel in efficacy and palatability. These are dependable antacid preparations without acid rebound, constipating or cathertic effects. Both the preparations provide symptomatic relief of hyperacidity associated with heartburn, acid ingestion or sour stomach.

Aluminium hydroxide gel, a slow acting antacid and an adsorbent with prolonged effect, has high neutralizing power. Magnesium Hydroxide possesses a slow but sustained acid neutralizing property. Antacids of both tablet and suspension possess adsorbent property. They form a protecting coating over the ulcer surface facilitating its healing; thus protecting the sensitive mucosa of stomach and duodenum from further irritation.

Tablet: Two tablets 1-3 hours after meal and at bed time or as directed by the physician.

Suspension: 2 tea spoonful 1-3 hours after meal and at bed time or as directed by the physician.

Long term use of any antacid results in alkaluria, which may predispose to nephrolithiasis by forming precipitation of calcium phosphate.

This is contraindicated in hypophosphataemia. It is also contraindicated in alkalosis and hypermagnesaemia where abdominal distention may be due to partial or complete intestinal obstruction.

Antacids reduce the absorption of tetracycline when given concomitantly. These should not be used concomitantly

This drug inhibits the absorption of following drugs: Azithromycin, cefpodoxime, ciprofloxacin, isoniazid, rifampicin, norfloxacin, ofloxacin, pivampicillin, tetracyclines, Gabapentin and phenytoin, Itraconazole, ketoconazole, Chloroquine, hydroxychloroquine and Phenothiazines.

It is advised to avoid antacid preparations in the first trimester of pregnancy.

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