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Topical Antifungal preparations

Miconazole topical cream is a broad-spectrum antimycotic which offers a high antifungal activity against dermatophytes, yeasts and other phyco-Asco and Adelomycetes, with a potent antibacterial activity against Gram-positive bacilli and cocci. Miconazole topical cream proved to be markedly effective in secondary infected mycoses, which under other treatments were resistant or reappeared. Miconazole topical cream does not stain skin or clothes.

The dosage is same for all the ages.

For skin infections: Apply some cream to the lesions twice daily and rub it well with finger until it has fully penetrated the skin. All lesions usually disappear after 2 to 5 weeks. Prolong treatment for some 10 days to prevent relapse.

For nail infections: Clip infected nail as shortly as possible. Apply some cream once daily to the infected nail and rub with your finger, cover nail with a non-perforated occlusive plastic bandage.

Also after loosening of the infected nail (from 2-3 weeks onwards) uniterrupted treatment should be continued until the growth of a new nail has set in and definite cure can be observed (usually after seven months or more).

Topical application of Miconazole Nitrate has almost no side effect.

No contraindication is known.

Miconazole Nitrate is intended for topical use. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered desirable.

Only small amounts of Miconazole nitrate are absorbed following local administration. However as with other imidazoles, Miconazole nitrate should be used with caution during pregnancy.

Store away from direct heat. Keep out of reach of children.

Mifepristone is indicated:

• As a medical alternative to surgical termination of intra-uterine pregnancy
• Softening and dilatation of the cervix uteri prior to surgical pregnancy termination
• Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons
• Labour induction for the expulsion of a dead fetus (fetal death in utero).

Drugs acting on the Uterus

Mifepristone is a synthetic steroid which blocks the effects of progesterone by competitively binding to the intracellular progesterone receptor. It sensitises the myometrium to the contraction-inducing action of prostaglandin. At higher doses, it blocks the effect of cortisol at the glucocorticoid receptor while increasing circulating cortisol concentrations.

As a medical alternative to surgical termination of intra-uterine pregnancy in early pregnancy: 600 mg Mifepristone in a single oral dose followed 36-48 hrs later, by the administration of a prostaglandin analogue Misoprostol 400 mcg orally (up to 49 days) or Gemeprost 1 mg vaginally (up to 63 days). 

Softening and dilatation of the cervix uteri prior to surgical pregnancy termination: 200 mg Mifepristone, followed 36-48 hrs later (but not beyond) by a surgical termination of pregnancy. 

Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons (to reduce the doses of prostaglandin): 600 mg of Mifepristone taken in a single oral dose, 36-48 hrs prior to scheduled prostaglandin administration which will be repeated as often as indicated. 

Labour induction for expulsion of a dead fetus (fetal death in utero): 600 mg of Mifepristone in a single oral daily dose for 2 consecutive days. Mifepristone alone leads to expulsion in about 60%. Labour should be induced by the usual methods if it has not started within 72 hrs following the first administration of Mifepristone.

There are no precautions for timing in relation to food.

It is very common for women to experience uterine contractions or cramping (10-45%) in the hours following prostaglandin intake. Bleeding increases with gestational age. Heavy bleeding occurs in about 5% of cases and from 0-1.4% may require haemostatic curettage. Uterine rupture, hypotension, skin rashes, urticaria, hot flashes and dizziness have been uncommonly reported.

Mifepristone must not be administered if there is doubt as to the existence or age of the pregnancy or if an extra-uterine pregnancy is suspected. An ultrasound scan and/or measurement of Beta-hCG must be performed before administration. For first trimester abortions, Mifepristone is contraindicated if the pregnancy is beyond 49 days of amenorrhoea when used with Misoprostol, or beyond 63 days of amenorrhoea when used with Gemeprost. Mifepristone should never be prescribed in patients with chronic adrenal failure, known allergy to Mifepristone or to any component of the product, severe asthma uncontrolled by corticosteroid therapy, porphyrias and renal failure, liver failure or malnutrition, or during breast feeding. Mifepristone is a lipophilic compound and may theoretically be excreted in the mother\'s breast milk, however no data is available.

Mifepristone is available only in single dose packaging. Administration must be under the supervision of a qualified physician. There are no data on the safety and efficacy of Mifepristone in women with chronic medical conditions such as cardiovascular, hypertensive, hepatic, respiratory or renal disease; insulin-dependent diabetes mellitus; severe anemia or heavy smoking. Women who are more than 35 years of age and who also smoke 10 or more cigarettes per day should be treated with caution because such patients were generally excluded from clinical trials of Mifepristone. Although there is no clinical evidence, the effectiveness of Mifepristone may be lower if Misoprostol is administered more than two days after Mifepristone administration.

ketoconazole, itraconazole, erythromycin and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone). Furthermore, rifampicin, dexamethasone, St John's Wort and certain anticonvulsants (phenytoin, phenobarbital, carbamazepine) may induce mifepristone metabolism (lowering serum levels of Mifepristone). Based on invitro inhibition information, co-administration of mifepristone may lead to an increase in serum levels of drugs that are CYP3A4 substrates.

Limited evidence suggests that co-administration of NSAIDs on the day of prostaglandin administration does not adversely influence the effects of Mifepristone or the prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of medical termination of pregnancy.

Pregnancy: Mifepristone is indicated for use in the termination of pregnancy (through 49 days’ pregnancy) and has no other approved indication for use during pregnancy.

Lactation: It is not known whether Mifepristone is excreted in human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of Mifepristone on infants are unknown, breast-feeding women should consult with their health care provider to decide if they should discard their breast milk for a few days following administration of the medications.

Use in children: Safety and effectiveness in pediatric patients have not been established.

Single doses of Mifepristone up to 2 gm caused no unwanted reaction. In the event of massive ingestion, signs of adrenal failure might occur. Acute intoxication may require admission to hospital and if relevant treatment with dexamethasone.

Store at 25° C.

This kit is indicated for early Menstrual Regulation (MR)/termination of pregnancy up to 9 weeks (63 days) of gestation.

Drugs acting on the Uterus, Prostaglandin analogues

Mifepristone: Mifepristone is a synthetic steroid with anti-progestational activity results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species, the compound inhibits the activity of endogenous or exogenous progesterone and the Menstrual Regulation (MR) results. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins.

Misoprostol: Misoprostol is a synthetic analogue of prostaglandin E1. It causes myometrial contraction by interacting with specific receptors on myometrial cells. This interaction results in a change in calcium concentration, thereby initiating muscle contraction. By interacting with prostaglandin receptors, Misoprostol causes the cervix to soften and the uterus to contract, resulting in the expulsion of the uterine contents.

This can only be prescribed by qualified medical professionals who are able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. The qualified medical professionals must also be able to provide surgical Intervention/MVA (Manual Vaccum Aspiration) in cases of incomplete abortion or severe bleeding or have made plans to provide such care through others and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

Day 1 (First visit): Mifepristone administration: One tablet of Mifepristone (200 mg) is taken in a single oral dose under the supervision of a qualified medical professional in a clinic, medical office or hospital.

Day 2 (Second visit): Misoprostol administration: 24-48 hours after ingesting the Mifepristone tablet, the patient takes four 200 microgram tablets (800 micrograms) of Misoprostol buccally or sublingually. Misoprostol tablets can be administered by the patient herself (place two tablets on each side of cheeck & gum or under the tongue). She should wait for 30 minutes. During the period immediately following the administration of Misoprostol, the patient may need medication for cramps or gastrointestinal symptoms. The patient should be given instructions on what to do if significant discomfort, excessive bleeding or other adverse reactions occur and should be given a phone number to call if she has questions following the administration of Misoprostol.

Day 10 to 14 (Third visit): Post-treatment examination: Patients must return to the clinic, medical office or hospital within 10 to 14 days after the administration of mifepristone. This visit is very important to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred.

Patients who have an ongoing pregnancy at this visit have a risk of fetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.

Mifepristone: The treatment procedure is designed to induce vaginal bleeding and uterine cramping necessary for Menstrual Regulation (MR). Commonly reported side effects were nausea, vomiting and diarrhoea. Pelvic pain, fainting, headache, dizziness, and asthenia occurred rarely.

Misoprostol: Gastro-intestinal side-effects like diarrhoea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting and constipation, shivering, hyperthermia, dizziness, pain due to uterine contractions, severe vaginal bleeding, shock, pelvic pain, uterine rupture (requiring surgical repair, hysterectomy and/or salpingo-oophorectomy).

Administration of Mifepristone is contraindicated in patients with any one of the following conditions: History of allergy or known hypersensitivity to Mifepristone, Misoprostol or other prostaglandin, confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy), IUD in place, chronic adrenal failure, haemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyria, If a patient does not have adequate access to medical facilities equipped to provide emergency treatment of incomplete process, blood transfusions and emergency resuscitation during the period from the first visit until discharged by the administering physician.

The patient should not give combination of Mifepristone & Misoprostol to anyone else. The combination of Mifepristone & Misoprostol has been prescribed for the patient's specific condition, it may not be the correct treatment for another person, and may be dangerous to the other person if she is or were to become pregnant. Any Intra Uterine Device [IUD] should be removed before treatment with Mifepristone begins. Menstrual Regulation (MR) by surgery is recommended in cases when combination of Mifepristone & Misoprostol fails to cause Menstrual Regulation (MR). Patients who have an ongoing pregnancy at last visit have a risk of foetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/ termination of pregnancy failures.

Mifepristone: Although specific drug or food interactions with Mifepristone have not been studied, on the basis of this drug's metabolism by CYP 3A4, it is possible that Ketoconazole, Itraconazole, Erythromycin and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone).

Misoprostol: Misoprostol has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on the absorption,blood levels and antiplatelet effects of therapeutic doses of aspirin.

Pregnancy- Mifepristone: is indicated for Menstrual Regulation (MR) (through 63 days pregnancy) and has no other approved indication for use during pregnancy. Patients who have an ongoing pregnancy at the last visit have a risk of foetal malformation resulting from the treatment. Surgical termination is recommended to manage Menstrual Regulation (MR) treatment failures.

Lactation-

• Mifepristone: It is not known whether Mifepristone is excreted through human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of Mifepristone on infants are unknown, breast-feeding women should consult with their doctor to decide if they should discard their breast milk for a few days following administration of the medications.
• Misoprostol: Although it is not known whether Misoprostol or Misoprostol is excreted through human milk, Misoprostol should not be administered to nursing mothers because the potential excretion of misoprostol acid could cause diarrhoea in nursing infants.

Use in Patients with Hepatic Impairment: Patients with hepatic disease should receive a decreased dose of Misoprostol.

Use in Patients with Renal Impairment: No routine dosage adjustment is recommended of Misoprostol in older patients or patients with renal impairment but the dosage may need to be reduced if the usual dose is not tolerated.

Mifepristone: No serious adverse reactions were reported in tolerance studies in healthy nonpregnant female and healthy male subjects where Mifepristone was administered in single doses greater than threefold of 600mg for Menstrual Regulation (MR). If a patient ingests a massive overdose, she should be observed closely for signs of adrenal failure.

Misoprostol: Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhoea, fever, palpitations, hypotension or bradycardia. Symptoms should be treated with supportive therapy. However, because Misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be the appropriate treatment for overdosage.

Store in a cool and dry place, protected from light.

Immunological Chemotherapy, Immunosuppressant

Mechanism of Action: Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA). MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis. The mechanism by which MPA inhibits the enzymatic activity of IMPDH appears to be related to the ability of MPA to structurally mimic both nicotinamide adenine dinucleotide cofactor and a catalytic water molecule. This prevents the oxidation of IMP to xanthose-5’-monophosphate which is the committed step in de novo guanosine nucleotide biosynthesis. MPA has more potent cytostatic effects on lymphocytes than on other cells because T- and B lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilize salvage pathways.

Pharmacodynamics: Mycophenolic acid, the active metabolite of mycophenolate mofetil, is a non-competitive, reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). Inhibition of IMPDH blocks the de novo synthesis of guanosine nucleotides which are necessary substrates for DNA and RNA synthesis. Unlike other cell types which can use the salvage pathway, B and T lymphocytes are dependent upon the de novo pathway for the generation of guanosine. Data from in vitro studies indicate that mycophenolic acid and/or mycophenolate mofetil inhibit mixed lymphocyte responses and human peripheral blood lymphocyte proliferation induced by a variety of mitogens and antigens. Mycophenolic acid decreases intracellular pools of guanosine triphosphate (GTP) and deoxyguanosine triphosphate (dGTP) in mitogen-stimulated human peripheral blood monocytes or T lymphocytic cell lines but has no effect on GTP concentrations in human neutrophils.

Transplant patients:
Standard dosage for prophylaxis of renal rejection

• Adults: A dose of 1 g administered orally twice a day (daily dose of 2 g) is recommended for use in renal transplant patients.
• Children (aged 3 months to 18 years): Patients with a body surface area of 1.25 to 1.5 m² may be prescribed Mycophenolate Mofetil Tablets at a dose of 750 mg twice daily (1.5 g daily dose). Patients with a body surface area >1.5 m² may be prescribed Mycophenolate Mofetil tablets at a dose of 1 gm twice daily (2 g daily dose).

Standard dosage for prophylaxis of cardiac rejection-

• Adults: A dose of 1.5 g administered orally (over not less than 2 hour) twice a day (daily dose of 3 g) is recommended for use in cardiac transplant patients.
• Children: no data are available for pediatric cardiac transplant patients.

Standard dosage for prophylaxis of hepatic rejection-

• Adults: A dose of 1.5 g orally twice a day (daily dose of 3 g) is recommended for use in hepatic transplant patients
• Children: no data are available for pediatric hepatic transplant patients.

Standard dosage for treatment of first or refractory renal rejection-

• Adults: A dose of 1.5 g administered orally twice a day (daily dose of 3 g) is recommended for management of first or refractory rejection.
• Children: no data are available for the treatment of first or refractory renal rejection in pediatric renal transplant patients.

Lupus nephritis patients:
Standard Dosage for Induction Therapy-

• Adults: A dose of 750 mg-1.5 g administered orally twice a day (daily dose of up to 3 g) is recommended
• Children: A dose of 600 mg/m² administered orally twice a day (up to a maximum of 2 g daily) is recommended

Standard Dosage for Maintenance Therapy-

• Adults: A dose of 500 mg-1 g administered orally twice a day is recommended
• Children: A dose of 300 mg/m² administered orally twice a day is recommended

Mycophenolate Mofetil should be used in combination with corticosteroids. Doses should be introduced gradually and adjusted according to clinical response. Therapeutic drug monitoring could help prevent sub-therapeutic exposure (Cmin≥3.0 mg/L or inter-dose AUC ≥35 h*mg/L).

The principal adverse reactions associated with the administration of Mycophenolate Mofetil includes diarrhea, leukopenia, sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, vomiting and there is evidence of a higher frequency of certain types of infections eg. opportunistic infections.

Mycophenolic acid is contraindicated in patients with a hypersensitivity to mycophenolic acid, or to any of its excipients. Mycophenolic acid is contraindicated during pregnancy due to its mutagenic and teratogenic potential. Mycophenolic acid is contraindicated in women who are breastfeeding.

Mycophenolic acid tablets are used with caution because it-

• Can increase new or reactive viral infections. Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation, or infections caused by polyomaviruses.
• Can cause blood dyscrasias including pure red cell aplasia (PRCA).
• Can cause serious GI tract complications (gastrointestinal bleeding, perforations and ulcers).
• May increase the risk of developing lymphomas and other malignancies, particularly of the skin.
• Use of live vaccines should be avoided during treatment with Mycophenolic acid.
• Patients should not donate blood during therapy.

Caution should be exercised with concomitant administration of Antacids, Azathioprine, Cyclosporin, Rifampin, Sevelamer, Cholestyramine, Acyclovir, Metronidazole, Hormonal contraceptives as these medicines may decrease Mycophenolic acid concentration.

Mycophenolate Mofetil is contraindicated in pregnancy and during breastfeeding. The safe use of Mycophenolate Mofetil during labor and delivery has not been established.

Geriatric population: Geriatric patients may be at an increased risk of adverse events such as certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal hemorrhage and pulmonary edema, compared with younger individuals.

In many of these cases no adverse events were reported. It is expected that an overdose of mycophenolate mofetil could possibly result in over suppression of the immune system and increase susceptibility to infections and bone marrow suppression. If neutropenia develops, dosing with Mycophenolate Mofetil should be interrupted or the dose reduced.

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

Moxifloxacin is indicated for the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community acquired pneumonia, uncomplicated & complicated skin and skin structure infections, complicated intra-abdominal infections and pelvic inflammatory disease.

4-Quinolone preparations

Moxifloxacin is a 4th generation synthetic broad spectrum, fluoroquinolone class of antibacterial drug. It has activity against a wide range of gram-positive, gram-negative, anaerobic and atypical bacteria including Mycoplasma pneumoniae. It acts by inhibiting topoisomerase II (DNA gyrase) and topoisomerase IV which are necessary for bacterial DNA replication, transcription & repair.

Acute bacterial sinusitis: 400 mg once daily 7-10 days.
Acute bacterial exacerbation of chronic bronchitis: 400 mg once daily 5-10 days.
Community-acquired pneumonia: 400 mg once daily 7-14 days.
Uncomplicated skin and skin structure infections: 400 mg once daily 7 days.
Complicated skin and skin structure infections: 400 mg once daily 7-21 days.
Complicated intra-abdominal infections: 400 mg once daily 5-14 days.
Pelvic inflammatory disease: 400 mg once daily 14 days.

Common side effects of Moxifloxacin include nausea, vomiting, diarrhea, headache and dizziness.

It is contraindicated in patients with a history of hypersensitivity to Moxifloxacin or other quinolones.

Moxifloxacin may cause an increased risk of tendinitis and tendon rupture. It should be discontinued if pain or inflammation in a tendon occurs. It should not be used in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients with receiving Class IA or Class III antiarrhythmic agents

Moxifloxacin absorption is decreased when administered with antacids, sucralfate, multivitamins, and multivalent cations (e.g. iron or zinc). Moxifloxacin may enhance the risk of convulsions with NSAIDs and bleeding with warfarin. So concomitant use of Moxifloxacin with them should be avoided.

US FDA pregnancy category C. Moxifloxacin is not recommended during pregnancy & lactation.

Renal or hepatic impaired patients: No dose adjustment is necessary for patients with renal or hepatic impairment.

Pediatric patients: Safety and effectiveness of Moxifloxacin in pediatric patients and adolescent less than 18 years of age have not been established.

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

This kit is indicated for early Menstrual Regulation (MR)/termination of pregnancy up to 9 weeks (63 days) of gestation.

Drugs acting on the Uterus, Prostaglandin analogues

Mifepristone: Mifepristone is a synthetic steroid with anti-progestational activity results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species, the compound inhibits the activity of endogenous or exogenous progesterone and the Menstrual Regulation (MR) results. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins.

Misoprostol: Misoprostol is a synthetic analogue of prostaglandin E1. It causes myometrial contraction by interacting with specific receptors on myometrial cells. This interaction results in a change in calcium concentration, thereby initiating muscle contraction. By interacting with prostaglandin receptors, Misoprostol causes the cervix to soften and the uterus to contract, resulting in the expulsion of the uterine contents.

This can only be prescribed by qualified medical professionals who are able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. The qualified medical professionals must also be able to provide surgical Intervention/MVA (Manual Vaccum Aspiration) in cases of incomplete abortion or severe bleeding or have made plans to provide such care through others and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

Day 1 (First visit): Mifepristone administration: One tablet of Mifepristone (200 mg) is taken in a single oral dose under the supervision of a qualified medical professional in a clinic, medical office or hospital.

Day 2 (Second visit): Misoprostol administration: 24-48 hours after ingesting the Mifepristone tablet, the patient takes four 200 microgram tablets (800 micrograms) of Misoprostol buccally or sublingually. Misoprostol tablets can be administered by the patient herself (place two tablets on each side of cheeck & gum or under the tongue). She should wait for 30 minutes. During the period immediately following the administration of Misoprostol, the patient may need medication for cramps or gastrointestinal symptoms. The patient should be given instructions on what to do if significant discomfort, excessive bleeding or other adverse reactions occur and should be given a phone number to call if she has questions following the administration of Misoprostol.

Day 10 to 14 (Third visit): Post-treatment examination: Patients must return to the clinic, medical office or hospital within 10 to 14 days after the administration of mifepristone. This visit is very important to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred.

Patients who have an ongoing pregnancy at this visit have a risk of fetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.

Mifepristone: The treatment procedure is designed to induce vaginal bleeding and uterine cramping necessary for Menstrual Regulation (MR). Commonly reported side effects were nausea, vomiting and diarrhoea. Pelvic pain, fainting, headache, dizziness, and asthenia occurred rarely.

Misoprostol: Gastro-intestinal side-effects like diarrhoea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting and constipation, shivering, hyperthermia, dizziness, pain due to uterine contractions, severe vaginal bleeding, shock, pelvic pain, uterine rupture (requiring surgical repair, hysterectomy and/or salpingo-oophorectomy).

Administration of Mifepristone is contraindicated in patients with any one of the following conditions: History of allergy or known hypersensitivity to Mifepristone, Misoprostol or other prostaglandin, confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy), IUD in place, chronic adrenal failure, haemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyria, If a patient does not have adequate access to medical facilities equipped to provide emergency treatment of incomplete process, blood transfusions and emergency resuscitation during the period from the first visit until discharged by the administering physician.

The patient should not give combination of Mifepristone & Misoprostol to anyone else. The combination of Mifepristone & Misoprostol has been prescribed for the patient's specific condition, it may not be the correct treatment for another person, and may be dangerous to the other person if she is or were to become pregnant. Any Intra Uterine Device [IUD] should be removed before treatment with Mifepristone begins. Menstrual Regulation (MR) by surgery is recommended in cases when combination of Mifepristone & Misoprostol fails to cause Menstrual Regulation (MR). Patients who have an ongoing pregnancy at last visit have a risk of foetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/ termination of pregnancy failures.

Mifepristone: Although specific drug or food interactions with Mifepristone have not been studied, on the basis of this drug's metabolism by CYP 3A4, it is possible that Ketoconazole, Itraconazole, Erythromycin and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone).

Misoprostol: Misoprostol has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on the absorption,blood levels and antiplatelet effects of therapeutic doses of aspirin.

Pregnancy- Mifepristone: is indicated for Menstrual Regulation (MR) (through 63 days pregnancy) and has no other approved indication for use during pregnancy. Patients who have an ongoing pregnancy at the last visit have a risk of foetal malformation resulting from the treatment. Surgical termination is recommended to manage Menstrual Regulation (MR) treatment failures.

Lactation-

• Mifepristone: It is not known whether Mifepristone is excreted through human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of Mifepristone on infants are unknown, breast-feeding women should consult with their doctor to decide if they should discard their breast milk for a few days following administration of the medications.
• Misoprostol: Although it is not known whether Misoprostol or Misoprostol is excreted through human milk, Misoprostol should not be administered to nursing mothers because the potential excretion of misoprostol acid could cause diarrhoea in nursing infants.

Use in Patients with Hepatic Impairment: Patients with hepatic disease should receive a decreased dose of Misoprostol.

Use in Patients with Renal Impairment: No routine dosage adjustment is recommended of Misoprostol in older patients or patients with renal impairment but the dosage may need to be reduced if the usual dose is not tolerated.

Mifepristone: No serious adverse reactions were reported in tolerance studies in healthy nonpregnant female and healthy male subjects where Mifepristone was administered in single doses greater than threefold of 600mg for Menstrual Regulation (MR). If a patient ingests a massive overdose, she should be observed closely for signs of adrenal failure.

Misoprostol: Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhoea, fever, palpitations, hypotension or bradycardia. Symptoms should be treated with supportive therapy. However, because Misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be the appropriate treatment for overdosage.

Store in a cool and dry place, protected from light.

This medication is used to help relieve moderate to severe pain. Morphine belongs to a class of drugs known as opioid (narcotic) analgesics. It works in the brain to change how your body feels and responds to pain.

Opioid analgesics

Morphine is a phenanthrene derivative which acts mainly on the CNS and smooth muscles. It binds to opiate receptors in the CNS altering pain perception and response. Analgesia, euphoria and dependence are thought to be due to its action at the mu-1 receptors while resp depression and inhibition of intestinal movements are due to action at the mu-2 receptors. Spinal analgesia is mediated by morphine agonist action at the K receptor.

Oral- Moderate to severe pain: 5-20 mg 4 hrly. Extended-release: 5-20 mg 12 hrly. Dosage is dependent on the severity of pain.

Intraspinal- Moderate to severe pain: Initially, 5 mg epidural inj; after 1 hr, additional doses of 1-2 mg may be given up to a total dose of 10 mg/24 hr if pain relief is unsatisfactory. A dose of 20-30 mg daily may be required in some patients. Liposomal inj: 10-20 mg depending on the type of surgery.

Intrathecal- Moderate to severe pain: 0.2-1 mg once daily or 1-10 mg daily for patients with opioid tolerance. Some patients may require a dose of up to 20 mg daily.

Intravenous- Acute pulmonary oedema:

• Adult: 5-10 mg via slow inj at 2 mg/min.
• Elderly: Half of the usual adult dose.

Intravenous- Pain associated with myocardial infarction:

• Adult: 5-10 mg at 1-2 mg/min followed by a further 5-10 mg as necessary.
• Elderly: Half of the usual adult dose.

Parenteral- 

• Moderate to severe pain: 5-20 mg; 2.5-10 mg via slow IV inj over 4-5 min with patient in recumbent position or a starting dose of 1-2 mg/hr via continuous IV infusion (max: 100 mg/day; 4 g/day in cancer patients). Doses may be adjusted according to severity of pain and patient's response.
• Premedication in surgery: Up to 10 mg, given 60-90 min before operation.

May be taken with or without food. May be taken with meals to reduce GI discomfort.

Nausea, vomiting, constipation, abdominal pain, dry mouth, anorexia, taste disturbance, dyspepsia, resp depression, sedation, dizziness, confusion, insomnia, headache, somnolence, involuntary muscle contractions, hyperhidrosis, rash, pruritus, asthenic conditions, HTN, bronchospasm, seizures, amenorrhoea, rhabdomyolysis, nystagmus.

Resp depression, obstructive airway disease, delayed gastric emptying, acute abdomen, heart failure secondary to chronic lung disease, known or suspected paralytic ileus, phaeochromocytoma. Concurrent admin with MAOIs or within 2 wk after treatment.

Patient with impaired resp function, severe bronchial asthma, convulsive disorders, acute alcoholism, delirium tremens, raised intracranial pressure, hypotension with hypovolaemia, cardiac arrhythmias, severe cor pulmonale, history of substance abuse, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, toxic psychoses. Opioid dependent patients. Renal and hepatic impairment. Pregnancy and lactation.

Additive depressant effects with other CNS depressants (e.g. sedatives, hypnotics, general anaesth, phenothiazines, other tranquilisers). May enhance the neuromuscular blocking action of skeletal muscle relaxants. Reduced analgesic effect with mixed agonist/antagonist opioid analgesics (e.g. pentazocine, nalbuphine, buprenorphine). Increased plasma concentrations with cimetidine. May reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. May delay the absorption of mexiletine. May antagonise the GI effect of cisapride, domperidone and metoclopramide. May produce hyperpyrexia and CNS toxicity with dopaminergics.

Parenteral or oral: C, D (if prolonged use/high doses at term)

Renal Impairment: Dosage may need to be reduced.
Hepatic Impairment: Dosage may need to be reduced.

Symptoms: Resp depression, pinpoint pupils, extreme somnolence progressing to stupor and coma, skeletal muscle flaccidity, cold and clammy skin and sometimes bradycardia and hypotension. Apnoea, circulatory collapse, and cardiac arrest may occur in severe cases.

Management: Re-establish adequate resp exchange through provision of a patent airway and institution of assisted or controlled ventilation. Oxygen, IV fluid, vasopressors and other supportive measures may be employed as necessary. Naloxone may be given as antidote.

Inj/oral preparations: Store between 15-30°C. Liposomal inj: Store between 2-8°C. Supp: Store below 25°C. Protect from light.

This medication is used to help relieve moderate to severe pain. Morphine belongs to a class of drugs known as opioid (narcotic) analgesics. It works in the brain to change how your body feels and responds to pain.

Opioid analgesics

Morphine is a phenanthrene derivative which acts mainly on the CNS and smooth muscles. It binds to opiate receptors in the CNS altering pain perception and response. Analgesia, euphoria and dependence are thought to be due to its action at the mu-1 receptors while resp depression and inhibition of intestinal movements are due to action at the mu-2 receptors. Spinal analgesia is mediated by morphine agonist action at the K receptor.

Oral- Moderate to severe pain: 5-20 mg 4 hrly. Extended-release: 5-20 mg 12 hrly. Dosage is dependent on the severity of pain.

Intraspinal- Moderate to severe pain: Initially, 5 mg epidural inj; after 1 hr, additional doses of 1-2 mg may be given up to a total dose of 10 mg/24 hr if pain relief is unsatisfactory. A dose of 20-30 mg daily may be required in some patients. Liposomal inj: 10-20 mg depending on the type of surgery.

Intrathecal- Moderate to severe pain: 0.2-1 mg once daily or 1-10 mg daily for patients with opioid tolerance. Some patients may require a dose of up to 20 mg daily.

Intravenous- Acute pulmonary oedema:

• Adult: 5-10 mg via slow inj at 2 mg/min.
• Elderly: Half of the usual adult dose.

Intravenous- Pain associated with myocardial infarction:

• Adult: 5-10 mg at 1-2 mg/min followed by a further 5-10 mg as necessary.
• Elderly: Half of the usual adult dose.

Parenteral- 

• Moderate to severe pain: 5-20 mg; 2.5-10 mg via slow IV inj over 4-5 min with patient in recumbent position or a starting dose of 1-2 mg/hr via continuous IV infusion (max: 100 mg/day; 4 g/day in cancer patients). Doses may be adjusted according to severity of pain and patient's response.
• Premedication in surgery: Up to 10 mg, given 60-90 min before operation.

May be taken with or without food. May be taken with meals to reduce GI discomfort.

Nausea, vomiting, constipation, abdominal pain, dry mouth, anorexia, taste disturbance, dyspepsia, resp depression, sedation, dizziness, confusion, insomnia, headache, somnolence, involuntary muscle contractions, hyperhidrosis, rash, pruritus, asthenic conditions, HTN, bronchospasm, seizures, amenorrhoea, rhabdomyolysis, nystagmus.

Resp depression, obstructive airway disease, delayed gastric emptying, acute abdomen, heart failure secondary to chronic lung disease, known or suspected paralytic ileus, phaeochromocytoma. Concurrent admin with MAOIs or within 2 wk after treatment.

Patient with impaired resp function, severe bronchial asthma, convulsive disorders, acute alcoholism, delirium tremens, raised intracranial pressure, hypotension with hypovolaemia, cardiac arrhythmias, severe cor pulmonale, history of substance abuse, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, toxic psychoses. Opioid dependent patients. Renal and hepatic impairment. Pregnancy and lactation.

Additive depressant effects with other CNS depressants (e.g. sedatives, hypnotics, general anaesth, phenothiazines, other tranquilisers). May enhance the neuromuscular blocking action of skeletal muscle relaxants. Reduced analgesic effect with mixed agonist/antagonist opioid analgesics (e.g. pentazocine, nalbuphine, buprenorphine). Increased plasma concentrations with cimetidine. May reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. May delay the absorption of mexiletine. May antagonise the GI effect of cisapride, domperidone and metoclopramide. May produce hyperpyrexia and CNS toxicity with dopaminergics.

Parenteral or oral: C, D (if prolonged use/high doses at term)

Renal Impairment: Dosage may need to be reduced.
Hepatic Impairment: Dosage may need to be reduced.

Symptoms: Resp depression, pinpoint pupils, extreme somnolence progressing to stupor and coma, skeletal muscle flaccidity, cold and clammy skin and sometimes bradycardia and hypotension. Apnoea, circulatory collapse, and cardiac arrest may occur in severe cases.

Management: Re-establish adequate resp exchange through provision of a patent airway and institution of assisted or controlled ventilation. Oxygen, IV fluid, vasopressors and other supportive measures may be employed as necessary. Naloxone may be given as antidote.

Inj/oral preparations: Store between 15-30°C. Liposomal inj: Store between 2-8°C. Supp: Store below 25°C. Protect from light.

This medication is used to help relieve moderate to severe pain. Morphine belongs to a class of drugs known as opioid (narcotic) analgesics. It works in the brain to change how your body feels and responds to pain.

Opioid analgesics

Morphine is a phenanthrene derivative which acts mainly on the CNS and smooth muscles. It binds to opiate receptors in the CNS altering pain perception and response. Analgesia, euphoria and dependence are thought to be due to its action at the mu-1 receptors while resp depression and inhibition of intestinal movements are due to action at the mu-2 receptors. Spinal analgesia is mediated by morphine agonist action at the K receptor.

Oral- Moderate to severe pain: 5-20 mg 4 hrly. Extended-release: 5-20 mg 12 hrly. Dosage is dependent on the severity of pain.

Intraspinal- Moderate to severe pain: Initially, 5 mg epidural inj; after 1 hr, additional doses of 1-2 mg may be given up to a total dose of 10 mg/24 hr if pain relief is unsatisfactory. A dose of 20-30 mg daily may be required in some patients. Liposomal inj: 10-20 mg depending on the type of surgery.

Intrathecal- Moderate to severe pain: 0.2-1 mg once daily or 1-10 mg daily for patients with opioid tolerance. Some patients may require a dose of up to 20 mg daily.

Intravenous- Acute pulmonary oedema:

• Adult: 5-10 mg via slow inj at 2 mg/min.
• Elderly: Half of the usual adult dose.

Intravenous- Pain associated with myocardial infarction:

• Adult: 5-10 mg at 1-2 mg/min followed by a further 5-10 mg as necessary.
• Elderly: Half of the usual adult dose.

Parenteral- 

• Moderate to severe pain: 5-20 mg; 2.5-10 mg via slow IV inj over 4-5 min with patient in recumbent position or a starting dose of 1-2 mg/hr via continuous IV infusion (max: 100 mg/day; 4 g/day in cancer patients). Doses may be adjusted according to severity of pain and patient's response.
• Premedication in surgery: Up to 10 mg, given 60-90 min before operation.

May be taken with or without food. May be taken with meals to reduce GI discomfort.

Nausea, vomiting, constipation, abdominal pain, dry mouth, anorexia, taste disturbance, dyspepsia, resp depression, sedation, dizziness, confusion, insomnia, headache, somnolence, involuntary muscle contractions, hyperhidrosis, rash, pruritus, asthenic conditions, HTN, bronchospasm, seizures, amenorrhoea, rhabdomyolysis, nystagmus.

Resp depression, obstructive airway disease, delayed gastric emptying, acute abdomen, heart failure secondary to chronic lung disease, known or suspected paralytic ileus, phaeochromocytoma. Concurrent admin with MAOIs or within 2 wk after treatment.

Patient with impaired resp function, severe bronchial asthma, convulsive disorders, acute alcoholism, delirium tremens, raised intracranial pressure, hypotension with hypovolaemia, cardiac arrhythmias, severe cor pulmonale, history of substance abuse, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, toxic psychoses. Opioid dependent patients. Renal and hepatic impairment. Pregnancy and lactation.

Additive depressant effects with other CNS depressants (e.g. sedatives, hypnotics, general anaesth, phenothiazines, other tranquilisers). May enhance the neuromuscular blocking action of skeletal muscle relaxants. Reduced analgesic effect with mixed agonist/antagonist opioid analgesics (e.g. pentazocine, nalbuphine, buprenorphine). Increased plasma concentrations with cimetidine. May reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. May delay the absorption of mexiletine. May antagonise the GI effect of cisapride, domperidone and metoclopramide. May produce hyperpyrexia and CNS toxicity with dopaminergics.

Parenteral or oral: C, D (if prolonged use/high doses at term)

Renal Impairment: Dosage may need to be reduced.
Hepatic Impairment: Dosage may need to be reduced.

Symptoms: Resp depression, pinpoint pupils, extreme somnolence progressing to stupor and coma, skeletal muscle flaccidity, cold and clammy skin and sometimes bradycardia and hypotension. Apnoea, circulatory collapse, and cardiac arrest may occur in severe cases.

Management: Re-establish adequate resp exchange through provision of a patent airway and institution of assisted or controlled ventilation. Oxygen, IV fluid, vasopressors and other supportive measures may be employed as necessary. Naloxone may be given as antidote.

Inj/oral preparations: Store between 15-30°C. Liposomal inj: Store between 2-8°C. Supp: Store below 25°C. Protect from light.

This kit is indicated for early Menstrual Regulation (MR)/termination of pregnancy up to 9 weeks (63 days) of gestation.

Drugs acting on the Uterus, Prostaglandin analogues

Mifepristone: Mifepristone is a synthetic steroid with anti-progestational activity results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species, the compound inhibits the activity of endogenous or exogenous progesterone and the Menstrual Regulation (MR) results. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins.

Misoprostol: Misoprostol is a synthetic analogue of prostaglandin E1. It causes myometrial contraction by interacting with specific receptors on myometrial cells. This interaction results in a change in calcium concentration, thereby initiating muscle contraction. By interacting with prostaglandin receptors, Misoprostol causes the cervix to soften and the uterus to contract, resulting in the expulsion of the uterine contents.

This can only be prescribed by qualified medical professionals who are able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. The qualified medical professionals must also be able to provide surgical Intervention/MVA (Manual Vaccum Aspiration) in cases of incomplete abortion or severe bleeding or have made plans to provide such care through others and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

Day 1 (First visit): Mifepristone administration: One tablet of Mifepristone (200 mg) is taken in a single oral dose under the supervision of a qualified medical professional in a clinic, medical office or hospital.

Day 2 (Second visit): Misoprostol administration: 24-48 hours after ingesting the Mifepristone tablet, the patient takes four 200 microgram tablets (800 micrograms) of Misoprostol buccally or sublingually. Misoprostol tablets can be administered by the patient herself (place two tablets on each side of cheeck & gum or under the tongue). She should wait for 30 minutes. During the period immediately following the administration of Misoprostol, the patient may need medication for cramps or gastrointestinal symptoms. The patient should be given instructions on what to do if significant discomfort, excessive bleeding or other adverse reactions occur and should be given a phone number to call if she has questions following the administration of Misoprostol.

Day 10 to 14 (Third visit): Post-treatment examination: Patients must return to the clinic, medical office or hospital within 10 to 14 days after the administration of mifepristone. This visit is very important to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred.

Patients who have an ongoing pregnancy at this visit have a risk of fetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.

Mifepristone: The treatment procedure is designed to induce vaginal bleeding and uterine cramping necessary for Menstrual Regulation (MR). Commonly reported side effects were nausea, vomiting and diarrhoea. Pelvic pain, fainting, headache, dizziness, and asthenia occurred rarely.

Misoprostol: Gastro-intestinal side-effects like diarrhoea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting and constipation, shivering, hyperthermia, dizziness, pain due to uterine contractions, severe vaginal bleeding, shock, pelvic pain, uterine rupture (requiring surgical repair, hysterectomy and/or salpingo-oophorectomy).

Administration of Mifepristone is contraindicated in patients with any one of the following conditions: History of allergy or known hypersensitivity to Mifepristone, Misoprostol or other prostaglandin, confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy), IUD in place, chronic adrenal failure, haemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyria, If a patient does not have adequate access to medical facilities equipped to provide emergency treatment of incomplete process, blood transfusions and emergency resuscitation during the period from the first visit until discharged by the administering physician.

The patient should not give combination of Mifepristone & Misoprostol to anyone else. The combination of Mifepristone & Misoprostol has been prescribed for the patient's specific condition, it may not be the correct treatment for another person, and may be dangerous to the other person if she is or were to become pregnant. Any Intra Uterine Device [IUD] should be removed before treatment with Mifepristone begins. Menstrual Regulation (MR) by surgery is recommended in cases when combination of Mifepristone & Misoprostol fails to cause Menstrual Regulation (MR). Patients who have an ongoing pregnancy at last visit have a risk of foetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/ termination of pregnancy failures.

Mifepristone: Although specific drug or food interactions with Mifepristone have not been studied, on the basis of this drug's metabolism by CYP 3A4, it is possible that Ketoconazole, Itraconazole, Erythromycin and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone).

Misoprostol: Misoprostol has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on the absorption,blood levels and antiplatelet effects of therapeutic doses of aspirin.

Pregnancy- Mifepristone: is indicated for Menstrual Regulation (MR) (through 63 days pregnancy) and has no other approved indication for use during pregnancy. Patients who have an ongoing pregnancy at the last visit have a risk of foetal malformation resulting from the treatment. Surgical termination is recommended to manage Menstrual Regulation (MR) treatment failures.

Lactation-

• Mifepristone: It is not known whether Mifepristone is excreted through human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of Mifepristone on infants are unknown, breast-feeding women should consult with their doctor to decide if they should discard their breast milk for a few days following administration of the medications.
• Misoprostol: Although it is not known whether Misoprostol or Misoprostol is excreted through human milk, Misoprostol should not be administered to nursing mothers because the potential excretion of misoprostol acid could cause diarrhoea in nursing infants.

Use in Patients with Hepatic Impairment: Patients with hepatic disease should receive a decreased dose of Misoprostol.

Use in Patients with Renal Impairment: No routine dosage adjustment is recommended of Misoprostol in older patients or patients with renal impairment but the dosage may need to be reduced if the usual dose is not tolerated.

Mifepristone: No serious adverse reactions were reported in tolerance studies in healthy nonpregnant female and healthy male subjects where Mifepristone was administered in single doses greater than threefold of 600mg for Menstrual Regulation (MR). If a patient ingests a massive overdose, she should be observed closely for signs of adrenal failure.

Misoprostol: Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhoea, fever, palpitations, hypotension or bradycardia. Symptoms should be treated with supportive therapy. However, because Misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be the appropriate treatment for overdosage.

Store in a cool and dry place, protected from light.

Montelukast Sodium is indicated for:

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Leukotriene receptor antagonists

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Adults & adolescents (15 years & older)-

• Asthma & Allergic Rhinitis: 10 mg/day 
• Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

• Asthma & Allergic Rhinitis: 5 mg/day 
• Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

• Asthma & Allergic Rhinitis: 4 mg/day 
• Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Antidote preparations, Immunosuppressant

Methotrexate inhibits dihydrofolic acid reductase. Dihydrofolates must be reduced to tetrahydrofolates by this enzyme before they can be utilized as carriers of one-carbon groups in the synthesis of p.r.n. nucleotides and thymidylate. Therefore, methotrexate interferes with DNA synthesis, repair, and cellular replication. Actively proliferating tissues such as malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder are in general more sensitive to this effect of methotrexate. When cellular proliferation in malignant tissues is greater than in most normal tissues, methotrexate may impair malignant growth without irreversible damage to normal tissues

Oral-

• Choriocarcinoma: 15-30 mg daily for 5 days, repeat after an interval of ≥1 wk for 3-5 courses.
• Acute lymphoblastic leukaemia: Maintenance: 15 mg/m2 once or twice wkly, with other agents.
• Burkitt's lymphoma: 10-25 mg daily for 4-8 days, repeated after 7-10 days.
• Psoriasis: 10-25 mg wkly as a single dose, adjust subsequent doses based on response.
• Rheumatoid arthritis: 7.5 mg once wkly, adjust by response. Not more than 20 mg/wk.
• Mycosis fungoides: 2.5-10 mg daily to induce remission.
• Crohn's disease: 12.5-22.5 mg once wkly for up to 1 yr.

Parenteral-

• Psoriasis: 10-25 mg wkly as a single dose. Adjust subsequent doses based on response. May be given via IV/IM admin.

Intramuscular-

• Choriocarcinoma: 15-30 mg daily for 5 days. Repeat after at least 1 wk for 3-5 courses. Alternatively, 0.25-1 mg/kg (max: 60 mg) every 48 hr for 4 doses followed by folinic acid rescue, repeat at intervals of 7 days for 4 or more courses.
• Mycosis fungoides: 50 mg wkly as a single dose or 2 divided doses.
• Acute lymphoblastic leukaemia: Maintenance: 15 mg/m² once or twice wkly, with other agents.
• Crohn's disease: 25 mg once wkly for 16 wk. Maintenance: 15 mg wkly.

Intrathecal-

• Meningeal leukaemia: 12 mg/m² (max 15 mg) once wkly for 2-3 wk, then once mthly. Alternatively, 200-500 mcg/kg every 2-5 day until CSF cell count is normalised.

Intravenous-

• Osteosarcoma: Initial recommended dose: 12 g/m² as a 4-hr infusion, followed by folinic acid, as part of combined therapy. May increase dose to 15 g/m² in subsequent treatments if initial dosage is insufficient to achieve peak serum methotrexate levels of 454 mcg/mL at the end of the infusion. Methotrexate infusion is administered on postoperative wk 4, 5, 6, 7, 11, 12, 15, 16, 29, 30, 44 and 45; in combination with other chemotherapy agents. Folinic acid can be given orally, IM or IV inj starting 24 hr after the beginning of the methotrexate infusion. Give via parenteral routes If patient experiences GI toxicity (e.g., nausea, vomiting). Usual dosage of folinic acid: 15 mg every 6 hr for a total of 60 hr or a total of 10 doses.
• Breast cancer: 10-60 mg/m² often with cyclophosphamide and fluorouracil.
• Advanced lymphosarcoma: Up to 30 mg/kg, followed by folinic acid rescue.
• Acute lymphoblastic leukaemia: Maintenance: 2.5 mg/kg every 14 days.

Should be taken on an empty stomach. Best taken on an empty stomach. May be taken with meals to reduce GI discomfort. Avoid taking with milk-rich products.

Ulceration of the mouth and GI disturbances (e.g. stomatitis and diarrhoea), bone marrow depression, hepatotoxicity, renal failure, skin reactions, alopecia, ocular irritation, arachnoiditis in intrathecal use, megaloblastic anaemia, osteoporosis, precipitation of diabetes, arthralgias, necrosis of soft tissue and bone, anaphylaxis, impaired fertility.

Severe renal or hepatic impairment, pre-existing profound bone marrow suppression in patients with psoriasis or rheumatoid arthritis, alcoholic liver disease, AIDS, pre-existing blood dyscrasias, pregnancy (in patients with psoriasis or rheumatoid arthritis), breast-feeding.

Hepatic or renal impairment, bone marrow depression, elderly, neonates. Ulcerative disorders of the GI tract. Monitor haematological, renal and hepatic function, and GI toxicity regularly.

Decreased effectiveness with folic acid and its derivatives.

Pregnancy category X. Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Nausea, vomiting, alopecia, melena, and renal failure.

Intramuscular: Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).

Intrathecal: Reconstitute to 2.5-5 mg/ml with normal saline, D5W, lactated Ringer's, or Elliott's B solution. Use preservative-free preparations.

Intravenous: Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).

Parenteral: Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).

Store at room temperature (15-25°C).

Antidote preparations, Immunosuppressant

Methotrexate inhibits dihydrofolic acid reductase. Dihydrofolates must be reduced to tetrahydrofolates by this enzyme before they can be utilized as carriers of one-carbon groups in the synthesis of p.r.n. nucleotides and thymidylate. Therefore, methotrexate interferes with DNA synthesis, repair, and cellular replication. Actively proliferating tissues such as malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder are in general more sensitive to this effect of methotrexate. When cellular proliferation in malignant tissues is greater than in most normal tissues, methotrexate may impair malignant growth without irreversible damage to normal tissues

Oral-

• Choriocarcinoma: 15-30 mg daily for 5 days, repeat after an interval of ≥1 wk for 3-5 courses.
• Acute lymphoblastic leukaemia: Maintenance: 15 mg/m2 once or twice wkly, with other agents.
• Burkitt's lymphoma: 10-25 mg daily for 4-8 days, repeated after 7-10 days.
• Psoriasis: 10-25 mg wkly as a single dose, adjust subsequent doses based on response.
• Rheumatoid arthritis: 7.5 mg once wkly, adjust by response. Not more than 20 mg/wk.
• Mycosis fungoides: 2.5-10 mg daily to induce remission.
• Crohn's disease: 12.5-22.5 mg once wkly for up to 1 yr.

Parenteral-

• Psoriasis: 10-25 mg wkly as a single dose. Adjust subsequent doses based on response. May be given via IV/IM admin.

Intramuscular-

• Choriocarcinoma: 15-30 mg daily for 5 days. Repeat after at least 1 wk for 3-5 courses. Alternatively, 0.25-1 mg/kg (max: 60 mg) every 48 hr for 4 doses followed by folinic acid rescue, repeat at intervals of 7 days for 4 or more courses.
• Mycosis fungoides: 50 mg wkly as a single dose or 2 divided doses.
• Acute lymphoblastic leukaemia: Maintenance: 15 mg/m² once or twice wkly, with other agents.
• Crohn's disease: 25 mg once wkly for 16 wk. Maintenance: 15 mg wkly.

Intrathecal-

• Meningeal leukaemia: 12 mg/m² (max 15 mg) once wkly for 2-3 wk, then once mthly. Alternatively, 200-500 mcg/kg every 2-5 day until CSF cell count is normalised.

Intravenous-

• Osteosarcoma: Initial recommended dose: 12 g/m² as a 4-hr infusion, followed by folinic acid, as part of combined therapy. May increase dose to 15 g/m² in subsequent treatments if initial dosage is insufficient to achieve peak serum methotrexate levels of 454 mcg/mL at the end of the infusion. Methotrexate infusion is administered on postoperative wk 4, 5, 6, 7, 11, 12, 15, 16, 29, 30, 44 and 45; in combination with other chemotherapy agents. Folinic acid can be given orally, IM or IV inj starting 24 hr after the beginning of the methotrexate infusion. Give via parenteral routes If patient experiences GI toxicity (e.g., nausea, vomiting). Usual dosage of folinic acid: 15 mg every 6 hr for a total of 60 hr or a total of 10 doses.
• Breast cancer: 10-60 mg/m² often with cyclophosphamide and fluorouracil.
• Advanced lymphosarcoma: Up to 30 mg/kg, followed by folinic acid rescue.
• Acute lymphoblastic leukaemia: Maintenance: 2.5 mg/kg every 14 days.

Should be taken on an empty stomach. Best taken on an empty stomach. May be taken with meals to reduce GI discomfort. Avoid taking with milk-rich products.

Ulceration of the mouth and GI disturbances (e.g. stomatitis and diarrhoea), bone marrow depression, hepatotoxicity, renal failure, skin reactions, alopecia, ocular irritation, arachnoiditis in intrathecal use, megaloblastic anaemia, osteoporosis, precipitation of diabetes, arthralgias, necrosis of soft tissue and bone, anaphylaxis, impaired fertility.

Severe renal or hepatic impairment, pre-existing profound bone marrow suppression in patients with psoriasis or rheumatoid arthritis, alcoholic liver disease, AIDS, pre-existing blood dyscrasias, pregnancy (in patients with psoriasis or rheumatoid arthritis), breast-feeding.

Hepatic or renal impairment, bone marrow depression, elderly, neonates. Ulcerative disorders of the GI tract. Monitor haematological, renal and hepatic function, and GI toxicity regularly.

Decreased effectiveness with folic acid and its derivatives.

Pregnancy category X. Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Nausea, vomiting, alopecia, melena, and renal failure.

Intramuscular: Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).

Intrathecal: Reconstitute to 2.5-5 mg/ml with normal saline, D5W, lactated Ringer's, or Elliott's B solution. Use preservative-free preparations.

Intravenous: Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).

Parenteral: Dilute powder with D5W or normal saline to a concentration ≤25 mg/ml (20 mg and 50 mg vials) and 50 mg/ml (1 g vial).

Store at room temperature (15-25°C).

Specific combined vitamin preparations

This preparation contains 8 essential vitamins with Cod Liver Oil. This provides extra protection for the children. It ensures for getting enough vitamins for children that help them to be grown up strong & stay healthy. Cod Liver Oil contains Vitamin A, Vitamin D, EPA & DHA. Vitamin A is essential for the immune system, bone growth, night vision, cellular growth, testicular and ovarian function, Vitamin D is essential for the absorption and utilization of calcium, which is also required for skeletal growth. EPA and DHA; omega-3 fatty acids, which are converted in the body to produce prostaglandins that affect a wide variety of physiological processes due to their modulating effect on the action of hormones. Omega-3 fatty acids relieve the symptoms of osteoarthritis, rheumatoid arthritis which also enhances immune function and promotes healthy blood circulation. It is thought that EPA and DHA may reduce the risk of coronary heart disease. DHA seems essential for normal brain development in unborn babies.

1-12 Months: 2.5 ml (½ teaspoon) daily
1-4 Years: 5 ml (1 teaspoon) daily
4 years up: 7.5 ml (1½ teaspoon) daily
Adult: 10 ml (2 teaspoons) daily.

This syrup can be taken with water or milk.

Generally well tolerated. However, a few allergic reactions may be seen.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

This medicine may accumulate in the body. So, should not be taken in overdose.

Some drug interaction may occur with- Erythromycin, Conjugated estrogens, Sodium bicarbonate, Chloramphenicol etc.

Should be taken on physician's advice.

Keep in cool and dry place and away from light. Keep away from children

This Jelly is indicated to enhance the comfort and ease of intimate activity with or without latex condoms. This personal lubricant can be safely applied directly to a genital body orifice or a latex condom. The product can be used inside condoms to facilitate application or outside for lubrication during intercourses.

Miscellaneous topical agents

Apply the desired amount of lubricant to your intimate areas. Reapply as needed. This Jelly is not applicable for pediatric Use.

No common side effects have been reported with this preparation. Few allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); new or worsening skin irritation may occur.

This Jelly is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

Discontinue if irritation or discomfort occurs. Do not eat and keep the gel away from nose, eye and open wounds. 

This Jelly is not a contraceptive and does not contain a spermicide. Keep out of reach of children and away from eyes and ears. Do not use if quality seal on the opening of the tube or bottle is broken or missing. Avoid use if pregnant or breast feeding unless prescribed by your doctor. Glycerol-based lubricants may slow sperm down, so if you're trying to have a baby, talk to your doctor before use.

Drug interaction-related data not found. If any abnormality consults with the doctor.

It may feel strange to have sex as the baby grows within, but so long as you're having a normal, healthy pregnancy, intercourse is generally considered safe but be sure to consult with doctor if you have any questions about safety. Avoid use if pregnant unless prescribed by physician. No known risk found during the lactation period.

Store at room temperature below 30°C. Do not freeze.

Targeted Cancer Therapy

Dasatinib, at nanomolar concentrations, inhibits the following kinases: BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. Based on modeling studies, dasatinib is predicted to bind to multiple conformations of the ABL kinase. In vitro, dasatinib was active in leukemic cell lines representing variants of imatinib mesylate sensitive and resistant disease. Dasatinib inhibited the growth of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) cell lines overexpressing BCR-ABL. Under the conditions of the assays, dasatinib was able to overcome imatinib resistance resulting from BCR-ABL kinase domain mutations, activation of alternate signaling pathways involving the SRC family kinases (LYN, HCK), and multi-drug resistance gene overexpression.

The recommended starting dosage of Dasatinib for:

• Chronic phase CML is 100 mg administered orally once daily.
• Accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL is 140 mg administered orally once daily.

Tablets should not be crushed or cut; they should be swallowed whole. Dasatinib can be taken with or without a meal, either in the morning or in the evening.

In clinical studies, treatment with Dasatinib was continued until disease progression or until no longer tolerated by the patient. The effect of stopping treatment on long-term disease outcome after the achievement of a cytogenetic response (including complete cytogenetic response [CCyR]) or major molecular response (MMR) is not known.

Reversible myelosuppression, neutropenia, anaemia, thrombocytopenia, fluid retention, pulmonary arterial HTN, QT prolongation, cardiac failure, arrhythmias, HTN, musculoskeletal pain, GI disturbances, headache, chills, fatigue, asthenia, myalgia, chest pain, arthralgia, pyrexia, mucositis, flushing, colitis, electrolyte disturbances, appetite and wt disturbances, rash, dermatitis, hyperhidrosis, pruritus, acne.

Concomitant use with CYP3A4 inhibitors (e.g. atazanavir, clarithromycin, erythromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin,  voriconazole or grapefruit juice); CYP3A4 inducers (e.g. carbamazepine, dexamethasone, phenytoin, phenobarbital, rifampicin or St John's wort); antacid. Pregnancy.

Patients with predisposing factors for QT prolongation (e.g. congenital long QT syndrome, hypokalaemia, hypomagnesaemia, on antiarrhythmic therapy, or receiving cumulative high doses of anthracyclines). Hepatic impairment. Lactation.

Concomitant use with drugs that have narrow therapeutic index (e.g. alfentanil, cisapride, ciclosporin, fentanyl, pimozide, quinidine, simvastatin, sirolimus, tacrolimus, ergot alkaloids) as it may increase the serum levels of these drugs. Increased risk of bleeding and thrombocytopenia with antiplatelet drugs, anticoagulants, and NSAIDs.

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

Pediatric Use: The safety and efficacy of Dasatinib in patients less than 18 years of age have not been established.

Geriatric Use: No differences in confirmed Complete Cytogenetic Response (cCCyR) and MMR were observed between older and younger patients. Of the 2712 patients in clinical studies of Dasatinib, 617 (23%) were 65 years of age and older, and 123 (5%) were 75 years of age and older. While the safety profile of Dasatinib in the geriatric population was similar to that in the younger population, patients aged 65 years and older are more likely to experience the commonly reported adverse reactions of fatigue, pleural effusion, diarrhea, dyspnea, cough, lower gastrointestinal hemorrhage, and appetite disturbance, and more likely to experience the less frequently reported adverse reactions of abdominal distention, dizziness, pericardial effusion, congestive heart failure, hypertension, pulmonary edema, and weight decrease, and should be monitored closely.

Hepatic Impairment: No dosage adjustment is necessary in patients with hepatic impairment. Caution is recommended when administering Dasatinib to patients with hepatic impairment.

Renal Impairment: There are currently no clinical studies with Dasatinib in patients with impaired renal function. Less than 4% of dasatinib and its metabolites are excreted via the kidney.

Symptoms: Significant platelet count reduction. Management: Closely monitor for myelosuppression. Supportive and symptomatic treatment.

Dasatinib tablets should be stored at 20°C to 25°C

Targeted Cancer Therapy

Dasatinib, at nanomolar concentrations, inhibits the following kinases: BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. Based on modeling studies, dasatinib is predicted to bind to multiple conformations of the ABL kinase. In vitro, dasatinib was active in leukemic cell lines representing variants of imatinib mesylate sensitive and resistant disease. Dasatinib inhibited the growth of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) cell lines overexpressing BCR-ABL. Under the conditions of the assays, dasatinib was able to overcome imatinib resistance resulting from BCR-ABL kinase domain mutations, activation of alternate signaling pathways involving the SRC family kinases (LYN, HCK), and multi-drug resistance gene overexpression.

The recommended starting dosage of Dasatinib for:

• Chronic phase CML is 100 mg administered orally once daily.
• Accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL is 140 mg administered orally once daily.

Tablets should not be crushed or cut; they should be swallowed whole. Dasatinib can be taken with or without a meal, either in the morning or in the evening.

In clinical studies, treatment with Dasatinib was continued until disease progression or until no longer tolerated by the patient. The effect of stopping treatment on long-term disease outcome after the achievement of a cytogenetic response (including complete cytogenetic response [CCyR]) or major molecular response (MMR) is not known.

Reversible myelosuppression, neutropenia, anaemia, thrombocytopenia, fluid retention, pulmonary arterial HTN, QT prolongation, cardiac failure, arrhythmias, HTN, musculoskeletal pain, GI disturbances, headache, chills, fatigue, asthenia, myalgia, chest pain, arthralgia, pyrexia, mucositis, flushing, colitis, electrolyte disturbances, appetite and wt disturbances, rash, dermatitis, hyperhidrosis, pruritus, acne.

Concomitant use with CYP3A4 inhibitors (e.g. atazanavir, clarithromycin, erythromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin,  voriconazole or grapefruit juice); CYP3A4 inducers (e.g. carbamazepine, dexamethasone, phenytoin, phenobarbital, rifampicin or St John's wort); antacid. Pregnancy.

Patients with predisposing factors for QT prolongation (e.g. congenital long QT syndrome, hypokalaemia, hypomagnesaemia, on antiarrhythmic therapy, or receiving cumulative high doses of anthracyclines). Hepatic impairment. Lactation.

Concomitant use with drugs that have narrow therapeutic index (e.g. alfentanil, cisapride, ciclosporin, fentanyl, pimozide, quinidine, simvastatin, sirolimus, tacrolimus, ergot alkaloids) as it may increase the serum levels of these drugs. Increased risk of bleeding and thrombocytopenia with antiplatelet drugs, anticoagulants, and NSAIDs.

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

Pediatric Use: The safety and efficacy of Dasatinib in patients less than 18 years of age have not been established.

Geriatric Use: No differences in confirmed Complete Cytogenetic Response (cCCyR) and MMR were observed between older and younger patients. Of the 2712 patients in clinical studies of Dasatinib, 617 (23%) were 65 years of age and older, and 123 (5%) were 75 years of age and older. While the safety profile of Dasatinib in the geriatric population was similar to that in the younger population, patients aged 65 years and older are more likely to experience the commonly reported adverse reactions of fatigue, pleural effusion, diarrhea, dyspnea, cough, lower gastrointestinal hemorrhage, and appetite disturbance, and more likely to experience the less frequently reported adverse reactions of abdominal distention, dizziness, pericardial effusion, congestive heart failure, hypertension, pulmonary edema, and weight decrease, and should be monitored closely.

Hepatic Impairment: No dosage adjustment is necessary in patients with hepatic impairment. Caution is recommended when administering Dasatinib to patients with hepatic impairment.

Renal Impairment: There are currently no clinical studies with Dasatinib in patients with impaired renal function. Less than 4% of dasatinib and its metabolites are excreted via the kidney.

Symptoms: Significant platelet count reduction. Management: Closely monitor for myelosuppression. Supportive and symptomatic treatment.

Dasatinib tablets should be stored at 20°C to 25°C

Cytotoxic immunosuppressants

Rituximab is a chimeric monoclonal antibody to CD20 antigen which regulates cell cycle initiation. It binds to the antigen on the cell surface, activating complement-dependent B-cell cytotoxicity; and to human Fc receptors, mediating cell killing through an antibody-dependent cellular toxicity.

Duration: Detectable in serum 3-6 mth after completion of therapy; B-cell recovery 6-12 mth following completion of therapy.

Intravenous (Adult)-

Non-Hodgkin's lymphoma, Refractory or relapsed follicular lymphoma: As a single agent, 375 mg/m² infusion once wkly, for 4 doses at an initial rate of 50 mg/hr. May increase by 50 mg/hr every 30 min. If tolerated, subsequent infusions can be started at 100 mg/hr and increased by 100 mg/hr every 30 min. Max rate: 400 mg/hr. When used with CVP (cyclophosphamide, vincristine and prednisolone) for follicular lymphoma or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) for diffuse large B-cell lymphoma, 375 mg/m² given on day 1 of the chemotherapy cycle after corticosteroid regimen, for up to 8 cycles. For patients who were treated with 6-8 cycles of CVP chemotherapy and have not progressed, 375 mg/m² may be given once wkly for 4 doses, may repeat every 6 mth, for up to 16 doses. Maintenance: 375 mg/m² given once every 3 mth (those who have responded to induction chemotherapy), once every 2 mth initiated 2 mth after the last dose of induction chemotherapy (previously untreated) for a max period of 2 yr.

Chronic lymphocytic leukaemia: 375 mg/m², given on the day prior to chemotherapy in cycle 1, followed by 500 mg/m² on day 1 (every 28 days) of cycles 2-6.

Rheumatoid arthritis: Given as two 1 g IV infusion doses, separated by 2 wk and in combination with methotrexate. Corticosteroids may be given before each infusion to minimise the risk and severity of infusion reactions.

Reactivation of hepatitis B virus. Fever and rigors. Pruritus, skin rashes, dyspnoea, bronchospasm, angioedema, transient hypotension, and flushing, asthenia, headache, rhinitis, thrombocytopenia, neutropenia, anaemia, abdominal pain, bowel obstruction, and perforation. Exacerbation of heart failure and angina pectoris. Reversible interstitial pneumonia and interstitial fibrosis. Depletion of immunoglobulin concentrations.

Hypersensitivity to murine proteins. Patients with active, severe infections. Severely immunocompromised state. Concomitant use with live viral vaccines. Lactation.

Extensive tumour burden, pulmonary insufficiency or pulmonary tumour infiltration; history of cardiac disease. Pregnancy.

Increased risk of renal toxicity with cisplatin.

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

Dilute the appropriate dose with sodium chloride 0.9% or glucose 5% to a final concentration of between 1 and 4 mg/mL.

Store between 2-8° C.

Cytotoxic immunosuppressants

Rituximab is a chimeric monoclonal antibody to CD20 antigen which regulates cell cycle initiation. It binds to the antigen on the cell surface, activating complement-dependent B-cell cytotoxicity; and to human Fc receptors, mediating cell killing through an antibody-dependent cellular toxicity.

Duration: Detectable in serum 3-6 mth after completion of therapy; B-cell recovery 6-12 mth following completion of therapy.

Intravenous (Adult)-

Non-Hodgkin's lymphoma, Refractory or relapsed follicular lymphoma: As a single agent, 375 mg/m² infusion once wkly, for 4 doses at an initial rate of 50 mg/hr. May increase by 50 mg/hr every 30 min. If tolerated, subsequent infusions can be started at 100 mg/hr and increased by 100 mg/hr every 30 min. Max rate: 400 mg/hr. When used with CVP (cyclophosphamide, vincristine and prednisolone) for follicular lymphoma or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) for diffuse large B-cell lymphoma, 375 mg/m² given on day 1 of the chemotherapy cycle after corticosteroid regimen, for up to 8 cycles. For patients who were treated with 6-8 cycles of CVP chemotherapy and have not progressed, 375 mg/m² may be given once wkly for 4 doses, may repeat every 6 mth, for up to 16 doses. Maintenance: 375 mg/m² given once every 3 mth (those who have responded to induction chemotherapy), once every 2 mth initiated 2 mth after the last dose of induction chemotherapy (previously untreated) for a max period of 2 yr.

Chronic lymphocytic leukaemia: 375 mg/m², given on the day prior to chemotherapy in cycle 1, followed by 500 mg/m² on day 1 (every 28 days) of cycles 2-6.

Rheumatoid arthritis: Given as two 1 g IV infusion doses, separated by 2 wk and in combination with methotrexate. Corticosteroids may be given before each infusion to minimise the risk and severity of infusion reactions.

Reactivation of hepatitis B virus. Fever and rigors. Pruritus, skin rashes, dyspnoea, bronchospasm, angioedema, transient hypotension, and flushing, asthenia, headache, rhinitis, thrombocytopenia, neutropenia, anaemia, abdominal pain, bowel obstruction, and perforation. Exacerbation of heart failure and angina pectoris. Reversible interstitial pneumonia and interstitial fibrosis. Depletion of immunoglobulin concentrations.

Hypersensitivity to murine proteins. Patients with active, severe infections. Severely immunocompromised state. Concomitant use with live viral vaccines. Lactation.

Extensive tumour burden, pulmonary insufficiency or pulmonary tumour infiltration; history of cardiac disease. Pregnancy.

Increased risk of renal toxicity with cisplatin.

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

Dilute the appropriate dose with sodium chloride 0.9% or glucose 5% to a final concentration of between 1 and 4 mg/mL.

Store between 2-8° C.

Anti-diarrhoeal Antimicrobial drugs, Macrolides

Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.

Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.

Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.

Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.

Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.

Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.

Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.

Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.

Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.

Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.

Known hypersensitivity to Erythromycin.

Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.

Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.

Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.

In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.

Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.

Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.