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Osimertinib: Uses,Dosage,Side Effects

Generic Name
Osimertinib
Therapeutic Class:
Oncology (Cytotoxic Chemotherapy)

Indications:
Osimertinib is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

Presentation:
Osimertinib 80: Each tablet contains Osimertinib Mesylate INN equivalent to Osimertinib 80 mg.

Description:
Osimertinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that binds to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletions) that predominate in non-small cell lung cancer (NSCLC) tumors following treatment with first-line EGFR-TKIs. As a third-generation tyrosine kinase inhibitor, Osimertinib is specific for the gate-keeper T790M mutation which increases ATP binding activity to EGFR and results in a poor prognosis for late-stage disease. Furthermore, Osimertinib has been shown to spare wild-type EGFR during therapy, thereby reducing non-specific binding and limiting toxicity.

Dosage & Administration:
The recommended dose of Osimertinib is 80 mg once a day until disease progression or unacceptable toxicity. Osimertinib can be taken with or without food. If a dose of Osimertinib is missed, do not make up the missed dose and take the next dose as scheduled.

Administration:
Administration To Patients Who Have Difficulty Swallowing Solids: Disperse tablet in 60 ml (2 ounces) of non-carbonated water only. Stir until the tablet is dispersed into small pieces (the tablet will not completely dissolve) and swallow immediately. Do not crush, heat, or ultrasonicate during preparation. Rinse the container with 120 ml to 240 ml (4 to 8 ounces of) water and immediately drink.

If administration via nasogastric tube is required, disperse the tablet as above in 15 ml of non-carbonated water, and then use an additional 15 ml of water to transfer any residues to the syringe. The resulting 30 ml liquid should be administered as per the nasogastric tube instructions with appropriate water flushes (approximately 30 ml).

Interaction:
Strong CYP3A4 Inducers: If concurrent use is unavoidable, increase Osimertinib dosage to 160 mg daily when coadministering with a strong CYP3A inducer. Resume Osimertinib at 80 mg 3 weeks after discontinuation of the strong CYP3A4 inducer

Side Effects:
Common side effects are Interstitial Lung Disease or Pneumonitis, QTc Interval Prolongation, Cardiomyopathy, Keratitis

Pregnancy & Lactation:
Use in Pregnancy: There are no or limited amount of data from the use of Osimertinib in pregnant women. Studies in animals have shown reproductive toxicity. Based on its mechanism of action and preclinical data, Osimertinib may cause foetal harm when administered to a pregnant woman. Administration of Osimertinib to pregnant rats was associated with embryolethality, reduced foetal growth, and neonatal death at exposures similar to what is expected in humans. Osimertinib is not recommended during pregnancy and in women of childbearing potential not using contraception.

Use in Lactation: It is not known whether Osimertinib or its metabolites are excreted in human milk. Administration to rats during gestation and early lactation was associated with adverse effects, including reduced growth rates and neonatal death. There is insufficient information on the excretion of Osimertinib or its metabolites in animal milk. A risk to the suckling child cannot be excluded. Breast-feeding should discontinue during treatment with Osimertinib.

Fertility: There are no data on the effect of Osimertinib on human fertility. Results from animal studies have shown that Osimertinib has effects on male and female reproductive organs and could impair fertility

Storage:
Store Osimertinib at room temperature between 20°C to 25°C. Safely throw away medicine that is out of date or that you no longer need. Keep Osimertinib and all medicines out of the reach of children.

Oseltamivir: Uses,Dosage,Side Effects

Generic Name
Oseltamivir
Therapeutic Class: Anti-Viral {Respiratory viral infections (Influenza)}

Indications:
Oseltamivir is indicated for the prevention of flu (influenza) in adults and adolescents aged 13 years and over who have been in contact with someone diagnosed with flu; treatment of flu (influenza) in adults and in children over one year of age when the influenza virus is circulating in the community

Presentation:
Oseltamivir 75 capsule: Each capsule contains Oseltamivir Phosphate INN 98.53 mg equivalent to Oseltamivir 75 mg.

Description:
Oseltamivir is a prodrug of oseltamivir carboxylate. Oseltamivir carboxylate inhibits neuraminidase (sialidase), a viral surface enzyme that is responsible for the replication and infectivity of influenza virus A and B, thereby preventing the release of viruses from infected cells.

Dosage & Administration:
Oseltamivir Phosphate may be taken with or without food. However, when taken with food, tolerability may be enhanced in some patients.

Standard oral dose for the treatment of influenza:
Adults and Adolescents: The recommended oral dose of Oseltamivir for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily for 5 days. Treatment should begin within 2 days of onset of symptoms of influenza.
Pediatric patients: The safety and efficacy of Oseltamivir for prophylaxis of influenza in pediatric patients younger than 13 years of age have not been established. 

Recommended oral dose for the treatment of influenza:
For prophylaxis of influenza in adults and adolescents 13 years and older following close contact with an infected individual: 75 mg once daily for at least 7 days. Therapy should begin within 2 days of exposure.
For prophylaxis during a community outbreak of influenza: 75 mg once daily. Safety and efficacy have been demonstrated for up to 6 weeks. The duration of protection lasts for as long as dosing is continued.

Administration: May be taken with or without food. May be taken with meals to reduce GI discomfort. Cap may be opened & mixed with sweetened food products eg chocolate syrup, sweetened condensed milk, apple sauce, or yogurt. Swallow mixture immediately after preparation.

Interaction:
Information derived from pharmacology and pharmacokinetic studies of Oseltamivir suggests that clinically significant drug interactions are unlikely. Co-administration with amoxicillin does not alter plasma levels of either compound.

Contraindications:
Oseltamivir is contraindicated in patients with known hypersensitivity to any of the components of the product.

Side Effects:
The most frequently reported adverse events are nausea and vomiting. These events generally of mild to a moderate degree and usually are occurred on the first 2 days of administration. Additional adverse events occurring in <1% of patients receiving Oseltamivir for treatment include unstable angina, anemia, pseudomembranous colitis, humerus fracture, pneumonia, pyrexia, and peritonsillar abscess.

Pregnancy & Lactation:
Pregnancy Category C: There are insufficient human data upon which to base an evaluation of the risk of Oseltamivir Phosphate to the pregnant woman or developing fetus.

Nursing Mothers: It is not known whether oseltamivir or oseltamivir carboxylate is excreted in human milk. Oseltamivir Phosphate should, therefore, be used only if the potential benefit for the lactating mother justifies the potential risk to the breast-fed infant.

Precautions & Warnings:
There is no evidence for the efficacy of Oseltamivir Phosphate in any illness caused by agents other than influenza viruses Types A and B. Efficacy of Oseltamivir Phosphate in patients who begin treatment after 40 hours of symptoms has not been established.

Use in Special Populations:
Hepatic Impairment: The safety and pharmacokinetics in patients with hepatic impairment have not been evaluated.
Renal Impairment: Dose adjustment is recommended for patients with a serum creatinine clearance <30 mL/min.
Geriatric Use: The safety of Oseltamivir Phosphate has been established in clinical studies.
Pediatric Use: The safety and efficacy of Oseltamivir Phosphate in pediatric patients younger than 1 year of age have not been studied. Oseltamivir Phosphate is not indicated for either treatment or prophylaxis of influenza in pediatric patients younger than 1 year of age.

Overdose:
At present, there has been no experience of overdose. Single-dose of up to 1000 mg of Oseltamivir has been associated with nausea and/or vomiting.

Storage:
Store at 25°C. Reconstituted suspension: Store between 2-8°C for up to 17 days or at 25°C for up to 10 days. Do not freeze.

Orlistat: Uses,Dosage,Side Effects

Generic Name
Orlistat
Therapeutic Class:
Anti-Obesity / Appetite-suppressant drugs

Presentation:
Orlistat Capsule: Each capsule contains Orlistat INN 120 mg

Indications:
Adults: Orlistat is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI)>30 kg/m2 and overweight patients (BMI >28 kg/m2 ) with associated risk factors such as type II diabetes, hyperlipidemia, and hypertension. Treatment with Orlistat should be discontinued after 12 weeks in patients who have not lost at least 5% of their body weight as measured at the start of drug therapy.

Adolescents (12 years & older): Obese adolescents should be treated with Orlistat only if an adequate reduction of body weight cannot be achieved by means of diet & increased physical activity. Treatment with orlistat should be considered in particular if complications of obesity are present.

Description:
Orlistat is a potent, specific, and long-acting lipase inhibitor. It exerts its therapeutic activity in the lumen of the stomach and upper small intestine by forming a covalent bond with the active serine site of gastric and pancreatic lipases. The inactivated enzyme is thus rendered unable to hydrolyze dietary fats in the form of triglycerides into absorbable free fatty acids and monoglycerides. As undigested triglycerides can not be absorbed, a caloric deficit arises which has a positive effect on weight control. Systemic absorption of orlistat is therefore not needed for the activity. At the recommended therapeutic dose of 120 mg three times a day, orlistat inhibit dietary fat absorption by approximately 30%.

Dosage & Administration:
The recommended dose of Orlistat is one 120 mg capsule to be taken immediately before, during, or up to one hour after each main meal. If a meal is missed or contains no fat the dose of Orlistat should be omitted. Doses of Orlistat above 120 mg three times daily have not been shown to provide additional benefits. The effect of Orlistat results in an increase in fecal fat 24-48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48-72 hours.

The safety & efficacy of Orlistat were investigated in clinical studies lasting up to 4 years. The recommended dose of Orlistat for adolescents is as same as adults.

Special dosage instruction: The tolerability and efficacy of Orlistat have not been studied in elderly patients, or patients with hepatic and/ or renal impairments.

Interaction:
No interactions with commonly prescribed medications such as alcohol, digoxin, nifedipine, oral contraceptives, phenytoin, pravastatin, warfarin, or metformin, glibenclamide, fibrates, furosemide, captopril, or atenolol have been observed in studies.

Contraindications:
Orlistat is contraindicated in patients with chronic malabsorption syndrome, in patients with cholestasis, and in patients who are hypersensitive to orlistat or to any of the other ingredients of the capsules.

Side Effects:
Common: Undesirable effects of Orlistat are largely gastrointestinal in nature. Common gastrointestinal side effects are oily spotting from the rectum, flatulence, fecal urgency, oily or fatty stool, abdominal discomfort, etc.

Rare: Influenza, anxiety. headache, fatigue, etc may rarely occur in some patients. Rare cases of hypersensitivity have been reported. The main clinical symptoms are pruritus, exanthema, urticaria, angioedema, and anaphylaxis.

Use in Pregnancy & Lactation:
No clinical data are available on pregnancy exposed to Orlistat. As it is not known whether Orlistat is excreted in breast milk. Orlistat should not be used during breastfeeding.

Precautions & Warnings:
Organic causes of obesity (e.g. hypothyroidism) should be excluded before prescribing Orlistat. Orlistat and cyclosporine should not be coadministered. Cyclosporine should be taken at least 2 hours before or after Orlistat in patients taking both drugs. Cyclosporine levels should be measured and frequently monitored.

In a clinical trial, the decrease in body weight with Orlistat therapy was less in type II diabetic patients than in non-diabetic patients. Antidiabetic drug treatment should be closely monitored during Orlistat therapy. Because of the improvement in glycemic control, the dose of oral antidiabetics or of insulin may need to be adjusted.

Patients should be advised to adhere to the dietary recommendations. The probability of occurrence of gastrointestinal side effects may increase when Orlistat is taken with a fatty meal. The daily intake of fat should be distributed between three main meals. Patients should be strongly encouraged to take a multivitamin supplement that contains fat-soluble vitamins to ensure adequate nutrition because orlistat has been shown to reduce the absorption of some fat-soluble vitamins & beta-carotene. In addition, the levels of vitamin D & beta carotene may be low in obese patients compared with non-obese patients.

Overdose:
Single doses of 800 mg Orlistat and multiple doses of up to 400 mg three times a day for 15 days have been studied in normal weight and obese subjects without significant adverse findings.

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

Ondansetron: Uses,Dosage,Side Effects

Generic Name
Ondansetron
Therapeutic Class:
Anti Emetic

Indications:
  • Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including Cisplatin >/= 50 mg/m2.
  • Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
  • Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
  • Prevention of postoperative nausea and/or vomiting.
  • Nausea-vomiting associated with pregnancy
  • Nausea-vomiting associated with gastroenteritis
Presentation:
Ondansetron tablet: Each film coated tablet contains Ondansetron Hydrochloride Dihydrate BP 9.977 mg equivalent to Ondansetron 8 mg.
Ondansetron 4 ml IV injection: Each ml contains Ondansetron Hydrochloride Dihydrate BP 2.49 mg equivalent to Ondansetron 2 mg.
Ondansetron oral solution: Each 5 ml contains Ondansetron Hydrochloride Dihydrate BP equivalent to Ondansetron 4 mg.
Ondansetron ODT tablet: Each tablet contains Ondansetron USP 4 mg.

Description:
Ondansetron is a selective 5-HT3 receptor antagonist. While its mechanism of action has not been fully characterized, Ondansetron is not a dopamine-receptor antagonist. Serotonin receptors of the 5-HT3 type are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. It is not certain whether Ondansetron's antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with the release of serotonin from the enterochromaffin cells of the small intestine.

Dosage & Administration:
1. Prevention of nausea-vomiting associated with chemotherapy
Adult:
Parenteral: 32 mg single dose infused over 15 minutes by diluting with 50 ml saline (5% dextrose or 0.9% NaCl) 30 minutes before starting chemotherapy. Alternative therapy: Three doses of 0.15 mg/kg body weight. The first dose is infused over 15 minutes beginning 30 minutes before the starting chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of administration.
Oral: 
Highly emetogenic cancer chemotherapy: 24 mg (three 8 mg tablet) administered 30 minutes before the start of emetogenic chemotherapy
Moderate emetogenic cancer chemotherapy: 8 mg (one 8 mg tablet) administered 30 minutes before the start of emetogenic chemotherapy. A further 8 mg dose should be administered after 8 hours of the first dose. One 8 mg tablet should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.

Pediatric:
Parenteral (6 months onwards): Three doses of 0.15 mg/kg body weight. The first dose is infused over 15 minutes beginning 30 minutes before starting moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of administration.
Oral (4-11 years): 4 mg tablet should be taken 30 minutes before the start of chemotherapy. The other 2 doses should be taken 4 and 8 hours after the first dose. Then 4 mg tablet should be administered 3 times a day (every 8 hours) for 1-2 days after completion of chemotherapy.

2. Prevention of nausea-vomiting associated with radiotherapy
Adults/ Geriatric/ Child of 12 years or over
The recommended dose is 8 mg tablet 3 times a day.
For total body irradiation: One 8 mg tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen:
One 8 mg tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen: One 8 mg tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day.

3. Prevention of post-operative nausea-vomiting
Adults/ Geriatric/ Child of 12 years or over
Parenteral: Undiluted 4 mg intravenously or intramuscularly immediately before induction of anesthesia. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes. Alternatively, the dose can be administered post-operatively if the patient experiences nausea and/or vomiting shortly after surgery
Oral: 16 mg (two 8 mg tablets) 1 hour before induction of anesthesia.

Pediatric (1-month to12 years)
Parenteral: Weighing less than 40 kg: 0.1-mg/kg body weight in a single dose. Weighing more than 40 kg: 4mg single dose The dose should be immediately before induction of anesthesia. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes.

Alternatively, the dose can be administered post-operatively if the patient experiences nausea and/or vomiting shortly after surgery.

4. Nausea-vomiting in gastroenteritis
Adult: 8 mg three times daily.
Pediatric (1 month or over): 0.15 mg/kg body weight three times daily.

5. Nausea vomiting in pregnancy 8 mg (1 tablet) 2-3 times daily

Ondansetron ODT administration procedure:
Ondansetron ODT should be removed from the blister gently. Then it should be immediately placed on top of the tongue where it will dissolve in seconds and swallowed with saliva. Administration with liquid is not necessary.

Side Effects:
Generally, Ondansetron is well tolerated. However few side effects including headache, diarrhea, fatigue, dizziness, and constipation may be seen after Ondansetron is administered.

Precautions:
Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.

Use in Pregnancy & Lactation:
Pregnancy: Pregnancy category B.
Nursing mother: It is not known whether Ondansetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ondansetron is administered to a nursing woman.

Interaction:
The following drugs should be used with caution when concomitantly used with Ondansetron:
Phenytoin, Carbamazepine, Rifampicin & Tramadol.

Overdose:
There is no specific antidote for Ondansetron overdose. Hypotension (and faintness) occurred in a patient that took 48 mg of Ondansetron tablets.

Use in Special Populations:
Geriatric Use: Dosage adjustment is not needed in patients over the age of 65.
Hepatic Impairment: A total daily dose of 8mg should not be exceeded (patients with severe hepatic impairment).
Renal Impairment: No dosage adjustment is recommended.

Storage:

Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.

Olopatadine Ophthalmic Solution 7 mg : Uses,Dosage,Side Effects

Generic Name
Olopatadine Ophthalmic Solution 7 mg
Therapeutic Class:
Anti Allergic

Indications:
This drug is indicated for the treatment of the sign and symptoms of allergic conjunctivitis (itchy, watery, red, irritated eyes).

Presentation:
Olopatadine Max Sterile Eye Drops: Each ml eye drop contains Olopatadine
Hydrochloride USP is equivalent to Olopatadine 7 mg.

Description:
Olopatadine is an inhibitor of the release of histamine from the mast cell and a relatively selective histamine H 1 -antagonist that inhibits histamine-induced inflammatory effects on human conjunctival epithelial cells.

Dosage & Administration:
Adults and children (age 2 years and above)
One drop in the conjunctival sac of the affected eye(s) once daily.

Side Effects:
Following adverse effects can be seen in some patients:
Headache, asthenia, blurred vision, burning or stinging, cold syndrome, dry
eye, foreign body sensation, hyperaemia, hypersensitivity, keratitis, lid edema,
nausea, pharyngitis, pruritus, rhinitis, sinusitis.

Precautions:
To prevent contaminating the dropper tip and solution, care should be taken not
to touch the eyelids or surrounding areas with the dropper tip of the bottle.
Patients should be advised not to wear a contact lens if their eye is red.

Use in Pregnancy & Lactation:
Pregnancy: Pregnancy category C. For this drug, no clinical data on exposed
pregnancies are available.
Lactation: It is not known if this medicine passes into breast milk, therefore it is
not recommended for use during breastfeeding.

Interaction:
Interactions with other medications have not been investigated in vivo.

Overdose:
No information is available.

Storage:
Keep out of the reach of children. Store in a cool, dry place, away from heat and direct light.
Do not use more than 4 weeks after opening

Olopatadine Ophthalmic Solution 2 mg: Uses,Dosage,Side Effects

Generic Name
Olopatadine Ophthalmic Solution 2 mg
Therapeutic Class:
Anti Allergic

Indications:
This drug is indicated for the treatment of the sign and symptoms of allergic conjunctivitis (itchy, watery, red, irritated eyes).

Presentation:
Olopatadine DS Eye Drops: Each ml eye drop contains Olopatadine Hydrochloride USP equivalent to Olopatadine 2 mg.

Description:
Olopatadine is an inhibitor of the release of histamine from the mast cell and a relatively selective histamine H1 -antagonist that inhibits histamine-induced inflammatory effects on human conjunctival epithelial cells.

Dosage & Administration:
Adults and children (above 2 years of age)
One drop in the conjunctival sac of the affected eye(s) once daily.

Side Effects:
Following adverse effects can be seen in some patients:
Headache, asthenia, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritus, rhinitis, sinusitis.

Precautions:
To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Patients should be advised not to wear a contact lens if their eye is red.

Use in Pregnancy & Lactation:
Pregnancy: Pregnancy category C. For this drug, no clinical data on exposed pregnancies are available.
Lactation: It is not known if this medicine passes into breast milk, therefore it is not recommended for use during breastfeeding.

Interaction:
Interactions with other medications have not been investigated in vivo.

Overdose:

No information is available.

Storage:
Keep out of the reach of children. Store in a cool, dry place, away from heat and direct light. Do not use it more than 4 weeks after opening.

Olopatadine Hydrochloride Solution (Ophthalmic): Uses,Dosage

Generic Name
Olopatadine Hydrochloride Solution (Ophthalmic) 
Therapeutic Class:
Ophthalmic

Indications:
Olopatadine is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

Presentation:
Olopatadine Sterile Eye Drops: Each ml contains 1.11 mg Olopatadine Hydrochloride USP equivalent to Olopatadine 1 mg.
Olopatadine DS Sterile Eye Drops: Each ml contains 2.22 mg of Olopatadine Hydrochloride USP equivalent to Olopatadine 2mg.

Description:
Olopatadine is an inhibitor of the release of histamine from the mast cell and a relatively selective histamine H1 -antagonist that inhibits histamine-induced inflammatory effects on human conjunctival epithelial cells.

Dosage & Administration:
Olopatadine: Adults and children (above 3 years of age). One drop of Lopadine in the conjunctival sac of the affected eye(s) twice daily.
Olopatadine DS: Adults and children (above 2 years of age). One drop in each affected eye once a day.

Side Effects:
Ocular: blurred vision, burning or stinging, conjunctivitis, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, pain, and ocular pruritus.
Non-ocular: asthenia, back pain, flu syndrome, headache, increased cough, infection, nausea, rhinitis, sinusitis, and taste perversion.

Precautions:
To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Patients should be advised not to wear a contact lens if their eye is red. Olopatadine should not be used to treat contact lens-related irritation.

Use in Pregnancy & Lactation:
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Therefore, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.
It is not known if this medicine passes into breast milk, therefore it is not recommended for use during breastfeeding.

Overdose:
No information is available.

Storage:
Store in a safe place. Keep out of the reach of children. Do not use it more than 4 weeks after opening.

Olopatadine Hydrochloride (Nasal Spray): Uses,Dosage,Side Effects

Generic Name
Olopatadine Hydrochloride (Nasal Spray)

Therapeutic Class:
Respiratory (Nasal Antihistamine preparations)

Indications:
Olopatadine Nasal Spray is an H1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older.

Presentation:
Each bottle contains 120 metered doses of Olopatadine Hydrochloride INN. Each actuation delivers Olopatadine Hydrochloride INN 665 mcg. (Equivalent to 600 mcg of Olopatadine).

Description:
Olopatadine, an antihistamine, works by blocking the action of histamine in the body, which reduces allergy symptoms. Olopatadine Hydrochloride treats sneezing, itching, runny nose, and other nasal symptoms of allergies. Olopatadine Nasal Spray contains 0.6% w/v Olopatadine (base) in a nonsterile aqueous solution with a pH of approximately 3.7. After initial priming (5 sprays), each metered spray from the nasal applicator delivers 100 microliters of the aqueous solution containing 665 mcg of olopatadine Hydrochloride, which is equivalent to 600 mcg of Olopatadine (base). Olopatadine Nasal Spray also contains benzalkonium chloride (0.01%), dibasic sodium phosphate, edetate disodium, sodium chloride, hydrochloric acid, and/or sodium hydroxide (to adjust pH), and purified water.

Dosage & Administration:
Administer Olopatadine Nasal Spray by the intranasal route only.
Adults and Adolescents 12 years of age and older: Two sprays per nostril twice daily.
Children 6 to 11 years of age: One spray per nostril twice daily.

Side Effects:
A bitter taste in the mouth, nosebleeds, or irritation/soreness in the nose may occur. Drowsiness may rarely occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Precautions:
Priming: Before initial use, prime Olopatadine Nasal Spray by releasing 5 sprays or until a fine mist appears. When Olopatadine Nasal Spray has not been used for more than 7 days, re-prime by releasing 2 sprays. Avoid spraying Olopatadine Nasal Spray into the eyes.
Patients should be informed to avoid spraying Olopatadine Nasal Spray in their eyes.

Use in Pregnancy & Lactation:
Pregnancy:
Pregnancy Category C; No adequate and well-controlled studies in pregnant women have been conducted. Olopatadine Nasal Spray should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.
Lactation:
It is not known whether topical nasal administration could result in sufficient systemic absorption to produce detectable quantities in human breast milk. Olopatadine Nasal Spray should be used by nursing mothers only if the potential benefit to the patient outweighs the potential risks to the infant.

Interaction:
Interaction with other medications has not been investigated.

Use in Special Populations:
There have been no reported overdoses with Olopatadine Nasal Spray.

Olmesartan Medoxomil + Hydrochlorothiazide: Uses,Dosage,Side Effects

Generic Name
Olmesartan Medoxomil + Hydrochlorothiazide
Therapeutic Class: 
Cardiovascular / Combined antihypertensive preparations

Indications:
Olmesartan Medoxomil & Hydrochlorothiazide 20 Plus is indicated for the treatment of hypertension.

Presentation:
Each tablet contains Olmesartan Medoxomil INN 20 mg and Hydrochlorothiazide BP 12.5 mg.

Description:
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of the AT1 receptor. Olmesartan does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).

Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing the excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume with consequent increases in plasma renin activity, increases aldosterone secretion & urinary Potassium loss, and decreases serum Potassium. The renin-aldosterone link is mediated by angiotensin II. So, co-administration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.

Dosage & Administration:
Hypertension
The usual starting dose of Olmesartan Medoxomil & Hydrochlorothiazide 20 Plus is one tablet once daily. Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks.

Patients with Renal Impairment:
The usual regimens of therapy with Olmesartan Medoxomil & Hydrochlorothiazide 20 Plus may be followed provided the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. So, Xyotil 20 Plus is not recommended.

Patients with Hepatic Impairment:
No dosage adjustment is necessary with hepatic impairment.

Side Effects:
The common side-effects are nausea, headache, dizziness, hyperuricemia, upper respiratory tract infection, and urinary tract infection. Other adverse effects are chest pain, back pain, peripheral edema, abdominal pain, dyspepsia, gastroenteritis, diarrhea.

Precautions:

  • Periodic determination of serum electrolytes should be performed at appropriate intervals to detect possible electrolyte imbalance like Hypokalemia, hyponatremia, and hypochloremic alkalosis.
  • Hyperuricemia may occur in certain patients receiving thiazide therapy.
  • Impaired renal function.
Use in Pregnancy & Lactation:
Safety and effectiveness in nursing mother & pregnancy have not been established. The drug should be discontinued during these conditions.

Interaction:
Olmesartan:
No significant drug interactions were reported in studies in which Olmesartan Medoxomil was co-administered with hydrochlorothiazide, digoxin, or warfarin in healthy volunteers. Olmesartan Medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce, or are metabolized by those enzymes are not expected.

Hydrochlorothiazide:
When administered concurrently, the following drugs may interact with thiazide diuretics:
  • Alcohol, Barbiturates, or Narcotics - Potentiation of orthostatic hypotension may occur.
  • Antidiabetic drugs (oral agents and Insulin) - Dosage adjustment of the antidiabetic drug may be required.
  • Other antihypertensive drugs - Additive effect or potentiation.
  • Corticosteroids, ACTH.
  • Lithium.
Overdose:
Olmesartan: 
Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia. Supportive treatment should be instituted.

Hydrochlorothiazide:
The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration) resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

Use in Special Populations:
Renal Impairment Patients: The usual regimens of therapy with this may be followed provided the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. So, this preparation is not recommended.

Hepatic Impairment Patients: No dosage adjustment is necessary with hepatic impairment.

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

Geriatric use: Clinical studies of Olmesartan and Hydrochlorothiazide combination did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.

Storage:
Store in a cool and dry place, protect from light and moisture. Keep out of the reach of children.

Olmesartan Medoxomil: Uses,Dosage,Side Effects

Generic Name
Olmesartan Medoxomil
Therapeutic Class:
Cardiovascular (Angiotensin-ll receptor blocker)

Indications:
Olmesartan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Presentation:
Olmesartan Medoxomil 20: Each tablet contains Olmesartan Medoxomil INN 20 mg.

Description:
Angiotensin II (formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme-ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of the AT1 receptor. Olmesartan does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).

Dosage & Administration:
Adult Hypertension:
The usual starting dose of Olmesartan is 20 mg once daily. Dosing should be individualized. Depending on the blood pressure response, the dose may be increased after 2 weeks to 40 mg. Olmesartan may be administered with or without food.

No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance < 40 mL/min), or with moderate to marked hepatic dysfunction.
If blood pressure is not controlled by Olmesartan alone, a diuretic may be added. Olmesartan may be administered with other antihypertensive agents.

Pediatric Hypertension (6 to 16 years of age):
The usual recommended starting dose of Olmesartan is 10 mg once daily for patients who weigh 20 to <35 kg, or 20 mg once daily for patients who weigh > 35 kg. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose may be increased to a maximum of 20 mg once daily for patients who weigh <35 kg or 40 mg once daily for patients who weigh > 35 kg.

Side Effects:
Treatment with Olmesartan is well tolerated. The common side effects are dizziness, diarrhea, headache, back pain, etc. Other adverse effects are chest pain, peripheral edema, abdominal pain, dyspepsia, gastroenteritis, vertigo, etc.

Precautions:
  • Periodic determination of serum electrolytes should be performed at appropriate intervals to detect possible electrolyte imbalance.
  • When pregnancy is detected, Olmesartan must be discontinued as soon as possible.
  • Hypotension in volume or salt-depleted patients may occur.
  • Impaired renal function
Use in Pregnancy & Lactation:
Pregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.

Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at a low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Interaction:
No significant drug interactions were reported in studies in which olmesartan medoxomil was coadministered with digoxin or warfarin in healthy volunteers. Olmesartan medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce, or are metabolized by those enzymes are not expected. The bioavailability of olmesartan is not significantly altered by the co-administration of antacids.

Overdose:
Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension occurs, supportive treatment should be initiated.

Storage:
Store in a cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.
















Olanzapine: Uses,Dosage,Side Effects

Generic Name
Olanzapine

Therapeutic Class:
Drugs of Nervous System (Atypical neuroleptic drugs)

Indications:
(Schizophrenia, Prevention of Bipolar Disorder, Mania)
Olanzapine is indicated for the acute and maintenance treatment of schizophrenia and related psychoses where positive symptoms (e.g. delusions, hallucinations, disordered thinking, hostility, and suspiciousness) and/or negative symptoms (e.g. flattened affect, emotional and social withdrawal, poverty of speech) are prominent. Olanzapine is indicated for the treatment of acute manic or mixed episodes in bipolar disorder, with or without psychotic features and with or without a rapid-cycling course

Presentation:
Olanzapine 5: Each tablet contains Olanzapine INN 5 mg.
Olanzapine 10: Each tablet contains Olanzapine INN 10 mg.

Description:
Olanzapine is a selective monoaminergic antagonist with high-affinity binding to Serotonin 5-HT, Dopamine, muscarinic, H1, and alpha receptors. It has a weak binding affinity to GABA-A, benzodiazepine, and beta-adrenergic receptors.

Dosage & Administration:
Schizophrenia, combination therapy for Mania, Bipolar Disorder:
The initial dose is 5-10 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage is greater than 10 mg daily only after reassessment. The maximum dose is 20 mg daily.

Monotherapy for Mania:
Initially 15 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage is greater than 15 mg only after reassessment. The maximum dose is 20 mg daily. Olanzapine can be given without regard to meals. Gradual tapering of the dose should be considered while discontinuing Olanzapine.

Olanzapine can be given without regard to meals. Gradual tapering of the dose should be considered while discontinuing Olanzapine.

Side Effects:
Very common undesirable effects are somnolence and weight gain. Besides increased appetite, elevated glucose levels, elevated triglyceride levels, dizziness, akathisia, Parkinson's disease, dyskinesia, orthostatic hypotension, mild and transient anticholinergic effects including constipation and dry mouth, asthenia, edema, and photosensitivity reaction, etc. may be observed.

Precautions:
Precaution should be taken in case of impaired renal, hepatic, cardiovascular, cerebrovascular, and respiratory failure, prostatic hypertrophy, paralytic ileus, diabetes mellitus, Parkinson's disease, and pregnancy.

Use in Pregnancy & Lactation:
Pregnancy: There are no adequate and well-controlled studies in pregnant women.
Lactation: Olanzapine is excreted in breast milk. Patients should be advised not to breastfeed an infant if they are taking Olanzapine.

Interaction:
Olanzapine may antagonize the effects of levodopa and dopamine agonists. Drugs that induce CYP1A2 or glucoronyl transferase enzymes e.g, Omeprazole and Rifampicin, may increase Olanzapine clearance. Inhibitors of CYP1A2 may potentially inhibit Olanzapine elimination. Carbamazepine may increase the clearance of Olanzapine. Concomitant administration of activated charcoal reduces the oral bioavailability of Olanzapine by 50-60%. Caution should be taken when Olanzapine is administered with centrally acting drugs and alcohol.

Use in Special Populations:
Children: Olanzapine has not been studied in subjects under 18 years of age.
Elderly patients (age 65 and over): starting dose 5 mg/day
Patients with hepatic, renal impairment: starting dose 5 mg/day

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

Pyridoxine Hydrochloride + Doxylamine Succinate: Uses,Side Effects

Generic Name
Pyridoxine Hydrochloride + Doxylamine Succinate
Therapeutic Class:
Anti-emetic drugs

Indications:
Pyridoxine Hydrochloride & Doxylamine Succinate tablet is indicated for the treatment of nausea and vomiting of pregnancy in women.

Presentation:
Pyridoxine Hydrochloride & Doxylamine Succinate tablet:
Each enteric-coated tablet contains Pyridoxine Hydrochloride BP 20 mg & Doxylamine Succinate BP 20 mg.

Description:
Doxylamine is an antihistamine that blocks Histamine (H1) receptor. It affects the vestibular system and decreases the stimulation of the vomiting center. Its muscarinic receptor inhibition may also play a role in antihistamine antiemetic activity. Pyridoxine (Vitamin B6) is a vitamin used to prevent nausea and vomiting due to its antiemetic properties.

Dosage & Administration:
Initially, take one Pyridox tablet orally at bedtime (Day 1). If this does adequately controls symptoms the next day, continue taking one tablet daily at bedtime only. However, if symptoms persist on Day 2, increase the daily dose to one tablet in the morning and one tablet at bedtime. The maximum recommended dose is two tablets per day, one in the morning and one at bedtime. Take on an empty stomach with a glass of water. Swallow the tablets whole. Do not crush, chew, or split Pyridoxine Hydrochloride & Doxylamine Succinate tablets. Take daily and not on an as-needed basis.

Side Effects:
Somnolence and falls or other accidents resulting from the effect of the combined use of Pyridoxine Hydrochloride & Doxylamine Succinate with CNS depressants.

Precautions:
Somnolence: Pyridox may cause somnolence due to the anticholinergic properties of doxylamine succinate, an antihistamine. Women should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery.
Pyridoxine Hydrochloride & Doxylamine Succinate use is not recommended if a woman is concurrently using central nervous system (CNS) depressants. The combination may result in severe drowsiness leading to falls or accidents. Pyridoxine Hydrochloride & Doxylamine Succinate has anticholinergic properties and therefore, should be used with caution in women with asthma, increased intraocular pressure, narrow-angle glaucoma, Stenosing peptic ulcer, Pyloroduodenal obstruction, or urinary bladder-neck obstruction.

Use in Pregnancy & Lactation:
Pyridoxine Hydrochloride & Doxylamine Succinate is intended for use in pregnant women.

Interaction:
The use of Pyridox is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the adverse central nervous system effects (the anticholinergic effects) of antihistamines. Concurrent use of alcohol and other CNS depressants (such as hypnotic sedatives and tranquilizers) with Pyridox is not recommended.

Overdose:
Doxylamine Succinate & Pyridoxine Hydrochloride is an extended-release or Delayed Release formulation; therefore, signs and symptoms of intoxication may not be apparent immediately. Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion, and tachycardia. At toxic doses, Doxylamine Succinate exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal failure, and death. If treatment is needed, it consists of gastric lavage or activated charcoal, whole bowel irrigation, and symptomatic treatment.

Storage:
Store in a cool and dry place away from light.

Pseudoephedrine + Guaiphenasine + Triprolidine:Uses,Dosage,Side Effects

Generic Name
Pseudoephedrine + Guaiphenasine + Triprolidine
Therapeutic Class:
Respiratory

Indications:
Pseudoephedrine, Guaiphenasine & Triprolidine indicated for the symptomatic relief of upper respiratory tract disorders accompanied by a productive cough that benefits from the administration of a nasal decongestant, a histamine H1-receptor antagonist, and an expectorant combination.

Presentation:
Each 5 ml syrup contains Guaiphenesin BP 100 mg, Pseudoephedrine Hydrochloride BP 30 mg, and Triprolidine Hydrochloride BP 1.25 mg.

Description:
Pseudoephedrine, Guaiphenasine & Triprolidine syrup is a mixture of expectorant, decongestant, and antihistamine agents. Guaiphenesin has an expectorant action. It reduces sputum viscosity by increasing the volume and water content of the bronchial secretion thereby facilitating the expectoration of sputum. Pseudoephedrine has direct and indirect sympathomimetic activity and is an effective upper respiratory decongestant. Pseudoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation of systolic blood pressure and considerably less potent in causing stimulation of the central nervous system. Triprolidine provides symptomatic relief in conditions believed to depend wholly or partly upon the triggered release of histamine. It is a potent competitive histamine H1-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which may cause drowsiness. Pseudoephedrine, Guaiphenasine & Triprolidine syrup is absorbed from the gastrointestinal tract. Guaiphenesin is metabolized and excreted in the urine. Pseudoephedrine is largely excreted unchanged in the urine together with small amounts of its hepatic metabolite and triprolidine is metabolized in the liver and excreted usually as metabolites in the urine.

Dosage & Administration:
Adult and Children over 12 years: 10 ml (2 teaspoonfuls) three times a day.
Children 6-12 years: 5 ml (1 teaspoonful) three times a day.
Children 2-5 years: 2.5 ml (1/2 teaspoonful) three times a day.

A physician’s advice is preferred before administering Pseudoephedrine, Guaiphenasine & Triprolidine to children aged less than 2 years.

Side Effects:
Central nervous system (CNS) depression or excitation may occur. Sleep disturbance and rarely hallucination have been reported. Skin rashes, tachycardia, dryness of the mouth, nose, and throat have occasionally been reported. Urinary retention has been reported occasionally in men receiving pseudoephedrine; prostatic enlargement could have been an important predisposing factor.

Precautions:
Pseudoephedrine, Guaiphenasine & Triprolidine may cause drowsiness and impair performance in tests of auditory vigilance. It may also impair the patient's ability to drive and also to use machinery. So, driving and operation of machinery should be avoided during treatment with Pseudoephedrine, Guaiphenasine & Triprolidine. Although there are no objective data, users of Pseudoephedrine, Guaiphenasine & Triprolidine should avoid the concomitant use of alcohol or other centrally acting sedatives. Although Pseudoephedrine has virtually no pressor effect in patients with normal blood pressure, Pseudoephedrine, Guaiphenasine & Triprolidine should be used with caution in patients taking antihypertensive agents, tricyclic antidepressants, or other sympathomimetic agents such as decongestant, appetite suppressants, and amphetamine-like psychostimulants. The effects of a single dose of Pseudoephedrine, Guaiphenasine & Triprolidine on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.
As with other sympathomimetic agents, caution should be exercised in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure, and prostatic enlargement. Pseudoephedrine, Guaiphenasine & Triprolidine should not be used for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or where cough is accompanied by excessive secretions unless directed by a physician.

Interaction:
Concomitant use of Pseudoephedrine, Guaiphenasine & Triprolidine with sympathomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants, and amphetamine-like psychostimulants or with monoamine oxidase inhibitors which interfere with the catabolism of sympathomimetic amines may occasionally cause a rise in blood pressure. Because of its pseudoephedrine content, Pseudoephedrine, Guaiphenasine & Triprolidine partially reverse the hypotensive action of drugs that interfere with sympathetic activity including guanethidine, methyldopa, alpha-adrenergic blocking agents.

Use in Pregnancy & Lactation:
Pregnancy:
Although pseudoephedrine, triprolidine, and guaiphenesin have been in widespread use for many years without apparent ill consequence, there are no specific data on their use during pregnancy. So, caution should therefore be exercised by balancing the potential benefit of treatment of the mother against any possible hazards to the developing fetus.
Lactation: Guaiphenesin is excreted in breast milk in small amounts with no effect expected on infants. Pseudoephedrine and triprolidine are excreted in breast milk in small amounts but the effect of this on breast-fed infants is not known. Caution should be exercised unless the potential benefit of treatment to the mother outweighs any possible risk of the infants.

Overdose:
The effects of acute toxicity from Pseudoephedrine, Guaiphenasine & Triprolidine may include drowsiness, irritability, restlessness, lethargy, dizziness, gastrointestinal discomfort, respiratory depression, convulsion, tremor, tachycardia, and hypertension. In case of overdose, necessary measures should be taken to maintain and support respiration and control convulsion. Gastric lavage may be undertaken if indicated. Catheterization of the bladder may be necessary.

Storage:
Store below 25 °C. Protect from light. Do not refrigerate.

Protamine crystallised Insulin Aspart: Uses,Dosage,Side Effects

Generic Name
Protamine crystallised Insulin Aspart
Therapeutic Class:
 Anti Diabetic/Rapid Acting Insulin

Indications:
Protamine crystallised Insulin Aspart is an insulin analog indicated to improve glycemic control in patients with diabetes mellitus.

Presentation:
Each ml solution contains 100 IU (equivalent to 3.50 mg) Insulin Aspart (rDNA).

Description:
Insulin Aspart rDNA is a sterile, clear solution of Insulin Aspart human insulin analog for
subcutaneous injection/infusion or intravenous injection. Protamine crystallised Insulin Aspart is a blood glucose-lowering agent with an earlier onset of action. Protamine crystallised Insulin Aspart produces more rapid onset of action compared to soluble human insulin. Insulin Aspart is homologous with regular human insulin with the exception of a single substitution of the amino acid Proline by aspartic acid in position B28 and is produced by recombinant DNA technology.

Dosage :
Insulin Aspart has a faster onset and a shorter duration of action than soluble human insulin. Due to the faster onset of action, Insulin Aspart should generally be given immediately before a meal. When necessary Insulin Aspart may be given soon after a meal.

Dosage of Insulin Aspart is individual and determined on the basis of the physician's advice in accordance with the needs of the patient. It should normally be used in combination with long-acting insulin given at least once a day.

The individual insulin requirement is usually between 0.5 and 1.0 IU/kg/day in adults and children over 2 years of age. In a meal-related treatment 50-70% of this requirement may be provided by Insulin Aspart and the remainder by long-acting insulin. Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet. Exercise taken immediately after a meal may increase the risk of hypoglycaemia.

Subcutaneous Injection: Insulin Aspart should be administered by subcutaneous injection in the abdominal region, buttocks, thigh, or upper arm. Because Insulin Aspart has a more rapid onset and a shorter duration of activity than human regular insulin, it should be injected immediately (within 5-10 minutes) before a meal Continuous Subcutaneous Insulin Infusion (CSII) by External Pump Insulin Aspart can also be infused subcutaneously by an external insulin pump. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen. Approximately 50% of the total dose is usually given as meal-related boluses of Insulin Aspart and the remainder is given as a basal infusion. When used with an infusion pump Insulin Aspart should not be mixed with any other insulin.

Intravenous Use: Insulin Aspart can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia. For intravenous use, Insulin Aspart should be used at concentrations from 0.05 IU/mL to 1.0 IU/mL insulin aspart in infusion systems using polypropylene infusion bags. Insulin Aspart has been shown to be stable in infusion fluids such as 0.9% sodium chloride.

Administration:
Instructions to be given to the patient Before injecting this Insulin:
  • According to the instruction given with ConviPen, insert the cartridge into the pen correctly & equip the needle
  • Gently turn the pen upside down 8-10 times until the insulin in the cartridge becomes uniformly mixed suspension
  • Remove the needle cap, discharge air bubbles in the catridge
  • Adjust the dosage button to get the correct dose & inject to the specific site
  • In order to avoid cross-contamination, do not let the needle touch anything during the process of preparation.
Side Effects:
Side effects of Insulin Aspart are hypoglycemia, allergic reactions, injection site reaction,
lipodystrophy, pruritus, and rash.

Precautions:
Dose adjustment and monitoring: Blood glucose should be monitored in all patients treated with
insulin. Insulin regimens should be modified cautiously and only under medical supervision

Use in Pregnancy & Lactation:
Pregnancy: Pregnancy category B.
Lactation: There are no restrictions on treatment with Protamine crystallised Insulin Aspart during lactation. Insulin treatment of the nursing mother should not affect the baby. However, the dosage may need to be adjusted.

Interaction:
A number of drugs affect glucose metabolism and may require dose adjustment.
The following substances may reduce the Insulin as well as Insulin Aspart requirements:
Oral anti-diabetic products, angiotensin-converting enzyme (ACE) inhibitors, disopyramide, fibrates,
fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates, and sulfonamide
antibiotics.
The following substances may increase the Insulin as well as Insulin Aspart requirements:
Thiazides, glucocorticoids, thyroid hormones, beta-sympathomimetics, growth hormone, and danazol.
Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.

Overdose:
A specific overdose for insulin cannot be defined, however, hypoglycemia may develop over
sequential stages if too high doses relative to the patient’s requirement are administered.
Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by
glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously. Glucose must also be given
intravenously if the patient does not respond to glucagon within 10 to 15 minutes.
Upon regaining consciousness administration of oral carbohydrate is recommended for the patient in
order to prevent relapse.

Storage:
Store at 2°C to 8°C in a refrigerator. Do not freeze. Protect from light.

Propofol: Uses,Dosage,Side Effects

Generic Name
Propofol
Therapeutic Class:
 Anesthetic / Critical Care / General (Intravenous) anesthetics

Indications:
Induction and maintenance of general anesthesia. Sedation during intensive care. Sedation for surgical and diagnostic procedures.

Presentation:
Propofol Injection: Each vial contains Propofol BP 200 mg.

Description:
Propofol is a highly lipid-soluble, short-acting intravenous general anesthetic. The onset of general anesthesia occurs in most patients within 30-60 seconds. Most patients return to consciousness rapidly and recover without confusion or nausea. They are usually completely orientated within only a few minutes from recovery and fit for discharge after only a few hours. Contrary to many other anesthetic agents, propofol is not clinically significantly accumulated during maintenance dosage. It is therefore most suitable for sedation during intensive care.

Its distribution can best be described by a three-compartment open model: rapid distribution from blood to tissues (half-life 2-3 minutes), rapid metabolic elimination from blood (half-life 30-60 minutes), and a slower final phase, during which propofol is eliminated from poorly perfused tissue. The rapid onset of action is based on the fact that propofol, as a lipid-soluble substance, easily passes the blood-brain barrier and is distributed to the central nervous system. The dosage, blood concentrations, and duration of anesthesia are directly interrelated on recommended dosages. Propofol is metabolized in the liver to inactive glucuronide and sulfate conjugates, which are excreted in the urine.

Dosage & Administration:
Adults
Induction of general anesthesia: The dosage of Propofol should be titrated individually against the response of the patient. The ordinary initial dosage in adults is 40 mg (4 ml) by slow intravenous bolus injection at intervals of 10 seconds until the clinical signs show the onset of anesthesia. The ordinary induction dose in a healthy patient below 55 years of age is 2.2-2.5 mg/kg. A dose of 1.0-1.5 mg/kg is often sufficient for the older patient. Lower doses, most often 20 mg (2 ml) at intervals of 10 seconds, are recommended for a patient of ASA grades 3 and 4.

Maintenance of general anesthesia: Anaesthesia can be maintained by administering Propofol either by continuous infusion or by repeat bolus injections to maintain sufficient anesthesia.

Continuous infusion: The required rate of infusion varies considerably between patients. At the onset of anesthesia (roughly the first 10-20 minutes), some patients may require a slightly higher infusion rate (8-10 mg/kg/h). However, sufficient anesthesia is normally achieved by infusing 4-6 (up to 12) mg/kg/h of Propofol. Repeat bolus injections: 25-50 mg (2.5-5.0 ml) bolus injections, depending on response.

Sedation during intensive care: A bolus injection of 1.0-2.0 mg/kg should be given first, followed by continuous infusion adjusted according to the required degree of sedation. An infusion rate of 0.3-4 mg/kg/h is usually sufficient.

Sedation for surgical and diagnostic procedures: Dosages shall be adjusted individually. Sufficient sedation for surgical and diagnostic procedures can usually be achieved by administering initially 0.5-1 mg/kg during 1-5 minutes and maintained by continuous at a rate of 1-4.5 mg/kg/h. A bolus dose of 10-20 mg can be given in addition, should deeper sedation be suddenly required. Lower doses of Propofol are often sufficient for the patient of ASA grades 3 and 4, and for the older patient.

Children
Propofol is not recommended for use in children less than 3 years of age as its safety has not been demonstrated.

Induction of general anesthesia: Dosage of Propofol in children shell be adjusted for weight and age. The mean induction dosage in children over 8 years is 2.5 mg/kg, given by slow intravenous injection until the clinical signs show the onset of anesthesia. Younger children may need slightly higher doses of propofol per kilogram of weight. Lower dosages are recommended for children of ASA grades 3 and 4.

Maintenance of general anesthesia: Anaesthesia can be maintained by administering Propofol either by continuous infusion or by repeat bolus injections. Dosage shall be adjusted individually, but an infusion rate of 9-15 mg/kg/h is usually sufficient to achieve satisfactory anesthesia.

Sedation during intensive care, surgical diagnostic procedures: Propofol is not recommended for sedation in children as its efficacy and safety have not been demonstrated. Although no causal relationship has been established, serious adverse events (including fatalities) have been reported in cases, where propofol has been used against recommendations. Adverse events have most commonly been seen in children with respiratory tract infections given doses in excess of those recommended for adults.

Method of administration
In order to reduce pain on injection, the induction dose of propofol may be mixed immediately before injection in the plastic syringe with lidocaine 10 mg/ml injection, in a ratio of 1 part of lidocaine injection for 20 parts of Propofol.

Propofol can be administered either undiluted or diluted for infusion. Before injection or dilution, each ampoule or vial shall be inspected for any irregularity. Should any changes be observed, the product shall not be used. Suitable equipment shall be used to ensure the correct rate of infusion. Volumetric infusion pumps and syringe pumps, for example, are suitable for this purpose. The ordinary infusion set used alone is not sufficient to prevent accidental overdosage reliably enough.

Compatibility: Propofol may be diluted only with 5% dextrose infusion. Dilution shall not exceed 1 in 5 (containing 2 mg/ml Propofol) and shall be prepared in a PVC infusion bag or glass infusion bottle. If a PVC infusion bag is used, the bag should be full and the dilution is prepared by withdrawing a volume of infusion fluid and replacing it with an equal volume of Propofol. Special attention shall be paid to preparing the dilution aseptically, immediately before administration. Any diluted solution shall be used within 6 hours of preparation. Any remaining solution shall be discarded.

Side Effects:
Local: Propofol is normally well tolerated. Its most common undesirable effect is pain at the site of injection that can be reduced by mixing the preparation with lidocaine or by injecting it into one of the larger veins of the forearm or the intercubital fossa. Thrombosis and phlebitis are rare. 
General: Hypotension and transient apnea may occur at the induction of anesthesia, and may be severe especially in patients who are in a poor general condition. Epileptic movement, convulsions, and dystonic reactions have been seen in rare cases. Pulmonary edema has also been reported. Headache, nausea, and, more rarely, vomiting may occur in some patients during recovery. Recovery may also be associated with another short period of impaired consciousness. Hypersensitivity has been reported in some cases, connected with anaphylactic symptoms such as marked hypotension, bronchospasm, edema, and facial erythema. Some cases of cardiac arrest have occurred in connection with the administration of propofol. In connection with long-term administration of propofol, green or reddish-brown discoloration of urine may occur. This is caused by the quinol metabolites of propofol and is not dangerous. As with other anesthetics, altered sexual behavior may occur.

Precautions:
Propofol and any equipment needed in its administration shall be treated strictly aseptically since Propofol contains no antimicrobial preservatives and as a lipid emulsion, it supports the growth of bacteria and other micro-organisms. When Propofol is to be aspirated, it must be drawn aseptically into a sterile syringe immediately after opening the ampoule or vial and administered without delay. Any fluids to be given simultaneously with Propofol shall be administered as close to the cannula site as possible. Propofol must not be administered via a microbiological filter.

Propofol and any equipment needed in its administration are for use in an individual patient, only. According to general recommendations related to the use of lipid emulsions, the infusion period of undiluted Propofol shall not exceed 12 hours at a time. Any unused Propofol and the infusion line shall be discarded at the end of infusion or not later than 12 hours from the start of infusion. The infusion may be repeated, if necessary.

Propofol should not be mixed prior to intravenous injection with solutions or infusion fluids other than 5 % dextrose or lidocaine 10 mg/ml injection. Propofol should be stored at a temperature not exceeding 25ºC. It must not be frozen. Any unused solution shall be discarded.

Use in Pregnancy & Lactation:
Due to insufficient experience, propofol shall not be used during pregnancy. Propofol is rapidly distributed to the fetus and shall therefore not be used for obstetric anesthesia. Safety to the neonate has not been established in cases, where propofol has been administered to lactating women.

Interaction:
Propofol has been used in association with spinal and epidural anesthesia as well as with various types of premeditates, muscle relaxants, inhalation anesthetics, and analgesics. No pharmacological incompatibility has been observed. Lower doses of Propofol may be sufficient in case Propofol is used as an adjunct to local anesthetic techniques. In doses applied clinically, propofol will not inhibit the synthesis of adrenocortical hormones. Simultaneous administration of opiates may potentiate respiratory depression caused by Propofol.

Overdose:
Overdosage may cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen, and cardiovascular depression by lowering the patient's head and elevating his/her legs. Pressor agents and plasma expanders or Ringer-type electrolyte solutions may be used, if necessary.

Reconstitution:
Propofol should not be mixed prior to intravenous injection with solutions or infusion fluids other than 5% dextrose or lidocaine 10 mg/ml injection.

Storage:
Propofol should be stored at a temperature not exceeding 25º C. It must not be frozen. Any unused solution shall be discarded.

Propantheline Bromide: Uses,Dosage,Side Effects

Generic Name
Propantheline Bromide
Therapeutic Class
:
Anti Spasmodic / Anticholinergics (antimuscarinics)

Indications:
Propantheline Bromide is indicated in the treatment of-
  • Adjunctive therapy in the treatment of peptic ulcer (gastric and duodenal)
  • Relief of the symptoms of gastritis (stomach upset, gastrointestinal bleeding, blood in vomit, blood in stool, persistent pain)
  • Symptomatic treatment of the diarrhea-related irritable bowel syndrome (irritable colon, spastic colon, acute enterocolitis, functional GI disorders, etc)
  • Urinary incontinence
  • Control of salivation and enuresis
  • Improves lactose intolerance
  • Prevents excessive sweating (Hyperhidrosis)
Presentation:
Each film-coated tablet contains Propantheline Bromide BP 15 mg

Description:
Propantheline Bromide acts by a dual mechanism of action.
  • Specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites
  • The direct effect upon smooth muscle (musculotropic). 
This medication is a muscarinic antagonist having antispasmodic properties. It reduces the effect of acetylcholine, a chemical released from nerves that stimulate muscles, by blocking the receptors for acetylcholine on smooth muscle. It also has a direct relaxing effect on smooth muscle. In addition, Propantheline inhibits gastrointestinal motility and decreases gastric acid secretion, and controls excessive pharyngeal, tracheal, and bronchial secretions. Other secretions like pancreatic juice, sweat, and saliva are also reduced.
Dosage & Administration:
The usual initial adult dose of Propantheline Bromide is 75 mg daily.
One tablet 30 min before each meal (15 mg three times daily)
Two tablets at bedtime
Dosage adjustment should be made according to the patient's individual response and tolerance. But the maximum daily dosage should not exceed 120 mg.

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

Side Effects:
The adverse effects of Propantheline Bromide are usually dose-related and are usually reversible when the therapy is discontinued. Variable degrees of dry mouth, dry skin, mydriasis might be noted. Other reported adverse effects include urinary retention, nausea, vomiting, constipation, headache, nervousness, mental confusion, etc.

Precautions:
Propantheline Bromide should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, hypertension, since anticholinergics may aggravate this condition.

Use in Pregnancy & Lactation:
Propantheline Bromide is in the Pregnancy Category C. Animal reproduction studies have not been conducted with propantheline bromide. Propantheline bromide should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in milk. Because many drugs are excreted in milk, caution should be exercised when propantheline bromide is administered to a nursing woman. Suppression of lactation may occur with anticholinergic drugs.
Pediatric use
Safety and effectiveness in pediatric patients have not been established

Interaction:
Antacids or Absorbent Antidiarrhoeals may reduce the absorption of propantheline bromide, therefore resulting in a reduction of its therapeutic effectiveness. Therefore, take two to three hours apart from doses of propantheline bromide. Anticholinergics may delay the absorption of other medication given concomitantly. Significant drug interaction also occurs with concomitant use of digoxin, haloperidol,
corticosteroids, ketoconazole, levodopa, opioid analgesics, phenothiazines, urinary alkalizer.

OverDose:
The symptoms of overdosage with Propantheline Bromide progress from an intensification of the usual side effects (from nausea and vomiting) to CNS disturbances (from restlessness and excitement to psychotic behavior), circulatory changes, (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis.

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

Procyclidine Hydrochloride: Uses,Dosage,Side Effects

Generic Name
Procyclidine Hydrochloride
Therapeutic Class:
Drugs of Nervous System (Antiparkinson drugs)

Indications:
All forms of Parkinson's disease -
  • Idiopathic Parkinsonism
  • Post-encephalitic Parkinsonism
  • Arteriosclerotic Parkinsonism
  • Extrapyramidal symptoms -
  • Pseudo-parkinsonism
  • Acute dystonic reactions
  • Akathisia.
Presentation:
Procyclidine 5: Each tablet contains Procyclidine Hydrochloride BP 5 mg.
Procyclidine Injection: Each 2 ml ampoule contains Procyclidine Hydrochloride BP 10 mg.

Description:
Procyclidine is an antimuscarinic tertiary amine, which acts by blocking excess acetylcholine at cerebral synapses. It also exhibits a direct antispasmodic effect on smooth muscle.

Dosage & Administration:
Oral-
Symptomatic treatment of Parkinsonism and drug-induced extrapyramidal syndrome:
Adult: Initially 2.5 mg t.i.d increased gradually by 2.5-5 mg every 2-3 days if required. The maintenance dose is 20-30 mg/day in 3 divided doses.
Elderly: The preferably lower range is required.
Children: Safety and efficacy have not been established in the pediatric age group; therefore, the use of Cyclid in this age group requires that the potential benefits be weighed against the possible risk to the child.
Parenteral-
Symptomatic treatment of Parkinsonism and drug-induced extrapyramidal syndrome:
Adult: Emergency cases 5-10 mg IM/IV. IM may be repeated if necessary after 20 min up to 20 mg/day

Side Effects:
Excitability, dizziness, hallucinations, dry mouth, blurred vision, constipation, urinary retention, agitation, restlessness, confusion and convulsions, sedation rather than stimulation, and gingivitis may be observed.

Precautions:
Precaution should be taken in case of hepatic & renal impairment, children, elderly, pregnancy, and lactation condition. Patients with mental disorders occasionally experience precipitation of a psychotic episode when Procyclidine is administered for the treatment of the extrapyramidal side-effects of neuroleptic. Procyclidine should not be withdrawn abruptly as rebound Parkinsonism symptoms may occur.

Use in Pregnancy & Lactation:

No data is advisable on the safe use of this drug in pregnancy and lactation.

Interaction:
Phenothiazines, anticonvulsants, levodopa, ketoconazole, monoamine oxidase inhibitors, adsorbent, anti-diarrhoeal, alcohol, anticholinergic drugs may interact with the Procyclidine.

Storage:
Protect from light and moisture, store below 25°C. Keep out of the reach of children.